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Searched for MAUDE (medical device) Adverse Event Cases containing the term: "depuy attune" and found more than 25 results.
Brand Name Manufacturer Event Date Patient Outcome Patient Narrative
DEPUY ATTUNE DEPUY 01/15/16 DEPUY ATTUNE KNEE IMPLANT IS FAILING. INSTABILITY IN MY KNEE. CONSTANT SEVERE PAIN. LOSS OF MOBILITY AND STRENGTH. KNEE GIVES OUT (EVEN WITH A BRACE). POPPING, CLICKING AND CLUNKING SOUNDS. KNEE IS CONSTANTLY WARM TO THE TOUCH.
DEPUY ATTUNE ROTATING PLATFORM TIBIAL IMPACTOR DEPUY 06/10/15 PIECE OF HANDLE OF THE DEPUY PINNACLE IMPACTOR BROKEN OFF WHILE IN USE DURING A RIGHT TOTAL HIP REPLACEMENT. PIECE RETRIEVED AND INSTRUMENT SEQUESTERED. AS SURGEON WAS USING THE DEPUY PINNACLE CULL IMPACTOR DURING A RIGHT TOTAL HIP REPLACEMENT,...
DEPUY ATTUNE DEPUY 02/13/15 I HAD TOTAL KNEE REPLACEMENT ON MY LEFT KNEE ON (B)(6) 2015. I HAD PHYSICAL THERAPY FOR APPROX 5 MONTHS. I STILL NEEDED FURTHER THERAPY BUT MY COVERAGE WENT NO FURTHER. I HAD WEAKNESS AND KNEE BUCKLING WHICH CONTINUED. I CONTINUED TO GO TO THE GYM...
UNKNOWN DEPUY ATTUNE PATELLA DEPUY ORTHOPAEDICS, INC. 1818910 06/30/16 NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS...
UNKNOWN DEPUY ATTUNE PATELLA 1818910 DEPUY ORTHOPAEDICS, INC. 09/03/14 THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED...
UNKNOWN DEPUY ATTUNE KNEE DEPUY ORTHOPAEDICS, INC. 07/13/16 NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS...
UNKNOWN DEPUY ATTUNE INSTRUMENT DEPUY ORTHOPAEDICS, INC. 12/11/15 THE ATTUNE FEMORAL TRIAL IS MISSING A BALL SEAL. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION...
UNKNOWN DEPUY ATTUNE INSTRUMENT DEPUY ORTHOPAEDICS, INC. 1818910 11/04/16 PATIENT WAS REVISED TO ADDRESS COMPLICATIONS FROM PRIMARY SURGERY THAT RESULTED IN BONE CUTS BEING MADE THAT CREATED A VARUS DEFORMITY.THE PRIMARY SURGEON INADVERTENTLY DRILLED THE FEMORAL ENTRY DRILL OUT OF THE FEMORAL CANAL CAUSING THE LEG...
UNKNOWN DEPUY ATTUNE PATELLAR COMPONENT DEPUY ORTHOPAEDICS, INC. 03/14/17 FOLLOW-UP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE CATALOG NUMBER AND LOT NUMBER AND THIS INFORMATION IS UNAVAILABLE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS...
UNKNOWN DEPUY ATTUNE TIBIAL TRAY DEPUY ORTHOPAEDICS, INC. 03/14/17 PATIENT WAS REVISED TO ADDRESS INFECTION AND TIBIAL LOOSENING. LOOSENING OCCURRED AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. LOOSENING WAS DUE TO INFECTION. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION....
UNKNOWN DEPUY ATTUNE TIBIAL INSERT DEPUY ORTHOPAEDICS, INC./REG. #1818910 06/01/13 THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A...
UNKNOWN DEPUY ATTUNE PATELLAR COMPONENT DEPUY ORTHOPAEDICS, INC.1818910 05/23/14 THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED...
UNKNOWN DEPUY ATTUNE TIBIAL INSERT DEPUY WARSAW 10/16/12 THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE PRODUCT CODE AND LOT CODE REQUIRED IN RETRIEVING THE DEVICE HISTORY RECORDS FOR REVIEWING AND SEARCHING THE WARSAW AND INTERNATIONAL COMPLAINT DATABASE WERE NOT PROVIDED. REQUESTS FOR...
UNKNOWN DEPUY ATTUNE FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC.1818910 05/23/14 THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT CODES AND LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL...
UNKNOWN DEPUY ATTUNE TIBIA COMPONENT DEPUY ORTHOPAEDICS, INC. 01/30/15 NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS...
UNKNOWN DEPUY ATTUNE TIBIA COMPONENT DEPUY ORTHOPAEDICS, INC. 10/01/14 THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. CLINICAL REPORT STATES PATIENT WAS REVISED DUE TO TIBIA LOOSENING. DEPUY CEMENT WAS USED. NO DEVICE ASSOCIATED...
UNKNOWN DEPUY ATTUNE FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC. 1818910 12/01/16 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS...
UNKNOWN DEPUY ATTUNE UNIVERSAL HANDLE 1818910 DEPUY ORTHOPAEDICS, INC. 02/03/15 UNIVERSAL HANDLE AND FEMORAL IMPACTOR BROKE. ADDITIONAL NARRATIVE: WITH REGARD TO THE IMPACTORS: EXPERT OPINION INDICATES THAT THE FAILURES ARE ASSOCIATED WITH ENVIRONMENTAL STRESS CRACKING (ESC). THE ATTUNE FEMORAL IMPACTOR HAS BEEN ANNEALED TO...
UNKNOWN DEPUY ATTUNE FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC. 1818910 07/29/14 PATIENT'S MEDIAL FEMORAL CONDYLE WAS FRACTURED. SURGICAL DELAY OF 1 HOUR. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS...
UNKNOWN DEPUY ATTUNE FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC. 1818910 11/15/16 PATIENT WAS REVISED TO ADDRESS FEMORAL MALPOSITIONING CAUSING LIMITED RANGE OF MOTION. CONCLUSION AND JUSTIFICATION STATUS FOR MDR: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE...
UNKNOWN DEPUY ATTUNE TIBIAL TRAY DEPUY ORTHOPAEDICS, INC. 01/28/16 PATIENT WAS REVISED TO ADDRESS TIBIA FAILURE. SPECIFIC FAILURE IS UNKNOWN. UPDATE 02/03/2016 XRAY REVIEWS SHOWS SUBSIDENCE FOR THE TIBIAL TRAY; IMPLANT MALPOSITION OF THE TIBIA TRAY INTO VARUS. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED...
UNKNOWN DEPUY ATTUNE FEMORAL COMPONENT DEPUY ORTHOPAEDICS, INC. 07/14/15 THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED...
UNKNOWN DEPUY ATTUNE TIBIAL TRAY DEPUY ORTHOPAEDICS, INC. 1818910 08/16/16 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS...
UNKNOWN DEPUY ATTUNE TIBIAL INSERT DEPUY ORTHOPAEDICS, INC. 1818910 11/14/16 NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION, HOWEVER REVIEW OF THE PROVIDED X-RAY AND EXPLANT PHOTOGRAPH CONFIRMS THE REPORTED POLYETHYLENE WEAR AND TIBIAL SUBSIDENCE. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR...
UNKNOWN DEPUY ATTUNE TIBIAL TRAY DEPUY ORTHOPAEDICS, INC. 1818910 03/14/16 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS...
UNKNOWN DEPUY ATTUNE TIBIAL TRAY DEPUY ORTHOPAEDICS, INC. 1818910 11/14/16 IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS...
UNKNOWN DEPUY ATTUNE TIBIA COMPONENT DEPUY ORTHOPAEDICS, INC. 07/09/15 NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS...
UNKNOWN DEPUY ATTUNE TIBIAL IMPACTOR DEPUY ORTHOPAEDICS, INC. 1818910 07/11/16 THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. UDI: UNAVAILABLE. CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE...
UNKNOWN DEPUY ATTUNE FEMORAL COMPONENT 1818910 DEPUY ORTHOPAEDICS, INC. 09/03/14 THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED...
UNKNOWN DEPUY ATTUNE FEMORAL IMPACTOR DEPUY ORTHOPAEDICS, INC. 1818910 09/12/16 THE ATTUNE FEMORAL IMPACTOR FRACTURED DURING THE IMPACTION OF IMPLANT. THE INVESTIGATION CONFIRMED THAT THE IMPACTOR HAD BROKEN AS REPORTED. EXPERT OPINION INDICATES THAT THE FAILURES ARE ASSOCIATED WITH ENVIRONMENTAL STRESS CRACKING (ESC). THE...