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Searched for MAUDE (medical device) Adverse Event Cases containing the term: ATTUNE\ and found more than 1,000 results.
Brand Name Manufacturer Event Date Patient Outcome Patient Narrative
ATTUNE ▸ DEPUY I HAD A TOTAL KNEE REPLACEMENT (B)(6) 2014 AND THOUGHT THAT MY ISSUES WITH PAIN, SWELLING, LACK OF BENDING WOULD BE MINIMALIZED. I AM VERY DISAPPOINTED AND RECENTLY CAME BACK FROM VACATION WITH MY FAMILY AND TRIED TO RIDE A ROLLER COASTER, BUT MY...
ENSOETM ▸ ADVANCED COOLING THERAPY, INC. D/B/A ATTUNE MEDICA 10/25/17 BACKGROUND: THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A KIDNEY TRANSPLANT AND HAD RECEIVED DIALYSIS THAT DAY. THE PATIENT WAS ADMINISTERED VANCOMYCIN PRE-SURGERY DUE TO IDENTIFIED BACTEREMIA IN THE DONOR KIDNEY. THE PATIENT HAD AN ANAPHYLACTIC...
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.
ATTUNE SHIM SZ5 5MM ▸ 11/02/17 IT WAS REPORTED THAT AN ATTUNE SZ 5-6 5MM SHIM WAS FOUND BROKEN IN A SET BY SPD. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ATTUNE PS FB INSRT SZ 6 5MM ▸ DEPUY IRELAND 9616671 11/02/17 DER STATES THAT SURGEON HAD DIFFICULTY IMPLANTING THE ATTUNE FB INSERT. HE INSERTED THE 5MM INSERT AT LEAST 4-5 TIMES AND COMPLAINED THAT HE DIDN'T FEEL THE IMPLANT WAS SEATING PROPERLY ON THE LATERAL SIDE. HE WAS USING A KNIFE BLADE TO SEE IF...
ATTUNE ▸ DEPUTY 01/12/15 DEPUY ATTUNE TOTAL KNEE SYSTEM IMPLANTED AND DEVELOPED "SPINNING OUT" ERROR A FEW MONTHS AFTER SURGERY. PATIENT REQUIRE RETURN TO SURGERY AND CONVERSION TO A POSTERIOR STABILIZED COMPONENT TO CORRECT MALFUNCTION.
ATTUNE ▸ DEPUY 01/13/15 PT IS A (B)(6) FEMALE WHO UNDERWENT A RIGHT TORAL KNEE ARTHROPLASTY ON (B)(6)2015. THERE WERE NO COMPLICATIONS NOTED FROM THE SURGERY AND THE PT TOLERATED THE PROCEDURE WELL. THE PT WAS DISCHARGED HOME FROM THE HOSPITAL ON (B)(6) 2015. X-RAYS OF...
ATTUNE ▸ DEPUY 01/12/15 PATIENT HAD A KNEE REPLACEMENT USING DEPUY ATTUNE HARDWARE AND DEVELOPED A "SPIN OUT" ERROR OF THE ROTATING PLATFORM. THE KNEE WAS REVISED PRIOR TO DISCHARGE AND THE ROTATING PLATFORM OF 6 MM IS EXCHANGED FOR A 10 MM. HE SUFFERS THE SAME "SPIN...
ATTUNE ▸ DEPUY 01/19/18 . PATIENT UNDERWENT A REMOVAL OF A DEPUY ATTUNE KNEE IMPLANT. THE PATIENT STATED THAT THE KNEE IMPLANT PREMATURELY FAILED. THE KNEE IMPLANT WAS REMOVED FROM THE PATIENT AND, UPON THE PATIENT'S REQUEST, SENT TO A THIRD PARTY LABORATORY FOR...
ATTUNE SHIM SZ7 5MM ▸ DEPUY ORTHOPAEDICS, INC. EXAMINATION OF THE RETURNED DEVICE CONFIRMS THE REPORTED EVENT OF SHIM DAMAGE/BREAKAGE. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT WEAR OUT DUE TO NORMAL INTENDED USE. BASED ON THE ROOT CAUSE OF PRODUCT WEAR OUT DUE TO NORMAL INTENDED USE, CORRECTIVE...
ATTUNE FEMORAL IMPACTOR ▸ DEPUY ORTHOPAEDICS, INC. THE COMPLAINT STATES DURING THE INSPECTION OF THE RETURNED DEVICES, THE ORTHOKIT TECHNICIAN NOTICED THAT THE FEMORAL IMPACTOR WAS BROKEN.. THE INVESTIGATION CONFIRMED THAT THE IMPACTOR HAD BROKEN AS REPORTED. EXPERT OPINION INDICATES THAT THE...
ATTUNE SHIM SZ3 8MM ▸ DEPUY ORTHOPAEDICS, INC. (B)(4). THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE 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...
ATTUNE IMPACTION HANDLE ▸ DEPUY 03/06/17 DURING A TOTAL KNEE REPLACEMENT SURGERY, FROM THE LOANER INSTRUMENT SET, THE DEPUY ATTUNE IMPACTOR HANDLE BROKE WHILE IN USE. IT BROKE INTO 3 PIECES. IT BROKE WHERE THE RED PLASTIC LEVEL IS ATTACHED AND SPRING CAME OUT. ALL PIECES WERE RETRIEVED...
ATTUNE FEMORAL IMPACTOR ▸ DEPUY ORTHOPAEDICS, INC. 1818910 02/07/17 THIS REPORT WAS FOUND TO BE A DUPLICATE OF 1818910-2017-13673. THIS REPORT, 1818910-2017-12413 WILL BE KEPT FOR INVESTIGATIONAL PURPOSES. REPORT 1818910-2017-13673 WILL BE REJECTED. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL...
ATTUNE SHIM SZ5 5MM ▸ DEPUY ORTHOPAEDICS, INC. DURING THE INSPECTION OF THE RETURNED DEVICE, THE ORTHOKIT TECHNICIAN NOTICED THAT THE INSTRUMENT WAS DAMAGED. THE POINTED END WAS BROKEN. EXAMINATION OF THE RETURNED DEVICES CONFIRMS THE REPORTED EVENT OF SHIM DAMAGE/BREAKAGE. THE ROOT CAUSE IS...
ATTUNE SHIM SZ3 7MM ▸ DEPUY ORTHOPAEDICS, INC. EXAMINATION OF THE RETURNED DEVICES CONFIRMS THE REPORTED EVENT OF SHIM DAMAGE/BREAKAGE. THE ROOT CAUSE IS CONTRIBUTED TO PRODUCT WEAR OUT DUE TO NORMAL INTENDED USE. BASED ON THE ROOT CAUSE OF PRODUCT WEAR OUT DUE TO NORMAL INTENDED USE,...
ATTUNE KNEE SYSTEM ▸ DEPUY SYNTHES 11/12/15 TOTAL KNEE REPLACEMENT NEVER QUIT SWELLING, BECOMES INFLAMED UNDER NORMAL USE, HEATS UP, CAUSES PAIN, FEELS UNSTABLE. DOCTORS SUSPECT BAD GLUE / CEMENT ALLOWING MOVEMENT IN LOWER PORTION. COULD NOT RETURN TO WORK. NOW ON NSSD AT AGE (B)(6). THEY...
ATTUNE KNEE REPLACEMENT ▸ DEPUY 08/22/16 I HAD AN ATTUNE DEPUY KNEE REPLACEMENT PUT INTO MY LEFT KNEE AND I HAVE HAD PAIN AND STIFFNESS EVER SINCE (B)(6) 2016. I'VE HAD AT LEAST 35 PHYSICAL THERAPIES AND ONE MUA BUT I GET NOWHERE. THIS HAS RUINED MY LIFE AS I HAVE HAD TO MISS IMPORTANT...
ATTUNE IMPACTION HANDLE ▸ DEPUY RAYNHAM 05/29/12 THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. LEVER ON ATTUNE IMPACTOR HANDLE BROKE, RELEASING SPRING. VISUAL EXAMINATION OF THE SUBMITTED IMPACTION HANDLE...
ATTUNE CONV FB PS TB TRL SZ4 ▸ 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 02/25/15 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...
ATTUNE SHIM SZ7 6MM ▸ DEPUY ORTHOPAEDICS, INC. 11/30/15 (B)(4). 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...
ATTUNE FEMORAL IMPACTOR ▸ DEPUY ORTHOPAEDICS, INC. 08/18/15 ONE FEMORAL IMPACTOR IS CRACKED AND ONE IS COMPLETELY BROKEN. CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES ONE FEMORAL IMPACTOR IS CRACKED AND ONE IS COMPLETELY BROKEN. THE INVESTIGATION CONFIRMED THAT THE IMPACTOR HAD BROKEN AS...
ATTUNE IMPACTION HANDLE ▸ DEPUY ORTHOPAEDICS, INC. 10/12/15 CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT THE CONNECTION PIECE IS BROKEN. THE INVESTIGATION COULD NOT CONFIRM THE COMPLAINT AS NO PRODUCT WAS RETURNED. IT SHOULD BE NOTED THAT A FIELD SAFETY NOTICE WAS ISSUED STATING THAT TO REDUCE THE...
ATTUNE CONV FB PS TB TRL SZ4 ▸ 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY...
ATTUNE FEMORAL IMPACTION HANDLE ▸ DEPUY 04/18/16 REUSABLE LOANER INSTRUMENTATION BROKE DURING TOTAL KNEE REPLACEMENT SURGERY. DURING TOTAL KNEE REPLACEMENT, SURGEON WAS UTILIZING THE DEPUY ATTUNE FEMORAL IMPACTION HANDLE AND THE RED COATED TIP PIECE AND SPRING BROKE OFF. ALL PIECES RECOVERED...
ATTUNE FEMORAL IMPACTION HANDLE ▸ DEPUY 03/28/16 REUSABLE LOANER INSTRUMENTATION BROKE DURING TOTAL KNEE REPLACEMENT SURGERY. DURING TOTAL KNEE REPLACEMENT SURGERY, SURGEON WAS UTILIZING THE DEPUY ATTUNE FEMORAL IMPACTION HANDLE AND THE RED COATED TIP THUMB PIECE AND SPRING BROKE OFF. ALL PIECES...
ATTUNE FEMORAL IMPACTOR ▸ * 05/04/15 PRODUCT CHIPPED DURING USE IN A KNEE PROCEDURE. SURGEON PERFORMING TOTAL KNEW PROCEDURE AND WHILE USING DEVICE, IT CRACKED AND A PIECE SHIPPED OFF.
ATTUNE IMPACTION HANDLE ▸ DEPUY ORTHOPAEDICS, INC. 1818910 10/27/15 MODULAR HANDLE TO IMPACT LOCKING MECHANISM SHATTERED DURING IMPACTION OF TIBIA. 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...
ATTUNE SPACER BLOCK ▸ DEPUY IRELAND 9616671 11/03/17 PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. BALSEAL SPRING DISASSOCIATED FROM THE SPACER BLOCK UPON TAKING IT APART AFTER THE SURGERY...
ATTUNE IMPACTION HANDLE ▸ DEPUY IRELAND 9616671 11/15/17 (B)(4). INVESTIGATION SUMMARY ==> CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES IT WAS REPORTED THAT THE RED BUTTONS/THUMB LATCHES BROKE OFF. THE INVESTIGATION CONFIRMED THAT THE LEVER HAD BROKEN AS REPORTED. IT SHOULD BE NOTED THAT A...