NA 86-7426Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295217893), received between Jul 17, 2017 and Jul 1, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Disassembly” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED A SEVERE INFECTION. SO, ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC NAIL WAS PUT IN. DOI: ON (B)(6) 2019, DOR: ON (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25681270 ↗
• MalfunctionApr 4, 2025Migration; Migration

  SUBJECT ID: (B)(6). STUDY NO: DOTS. CLINICAL NOTIFICATION RECEIVED FOR REVISION OF LEFT KNEE TO ADDRESS SEVERE PAIN AND IMPLANT LOOSENING/MIGRATION OF THE TIBIAL TRAY. DATE OF IMPLANTATION: (B)(6) 2001. DATE OF ONSET: (B)(6) 2015. DATE OF REVISION: (B)(6) 2016. (LEFT KNEE). ON (B)(6) 2001, THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY. ON (B)(6) 2015, THE PATIENT IS NOTED TO HAVE PAIN LOOSE TIBIA, MIGRATION/LOOSENING: TIBIAL. DEFINITELY DEVICE RELATED. ON (B)(6) 2016, PATIENT NOTED TO HAVE SEVERE PAIN RELATED TO DEVICE, NOT RELATED TO PROCEDURE LEFT KNEE (PART/LOT PAGE 1 OF 1 DOTS: THE FOLLOWING KNEE ADVERSE EVENT HAS BEEN EDITED FOR (B)(6)). ON (B)(6) 2016, THE PATIENT HAD A REVISION LEFT TOTAL KNEE TO ADDRESS FAILED TIBIAL COMPONENT. THE INDICATIONS FOR SURGERY INCLUDE TIBIAL LOOSENING, FAILURE OF FIXATION. DURING THE PROCEDURE THE SURGEON OBSERVED THAT THE TIBIAL COMPONENT WAS GROSSLY LOOSE, AS THERE WAS DEBONDING FROM THE CEMENT BUT THE MEDICAL CEMENT HAD FAILED AND THE IMPLANT HAD TIPPED INTO VARUS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE INCLUDING DEPUY PATELLA. (SURGERY PAGE 4,5 OF 5 (B)(4) CLINICAL NOTES AD (B)(6) 2023). ON (B)(6) 2018 MEDICAL RECORDS NOTE TH

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain

  MAUDE report 21772605 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20333772 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INSTABILITY & PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18967912 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TC3 REVISION KNEE? INFECTED - UNSTABLE SIGNASURE CAME BACK NEGATIVE FOR INFECTION PREVIOUS IV DRUG ABUSER, HIGH FUNCTIONING KNEE PLAN A- ATTUNE REVISION, PLAN B - ATTUNE HINGE PLAN C - TC3 FEMUR REVISION IF TIBIA WELL FIXED IN SITU - TC3FEMUR SIZE 4 PLUS DISTAL AND POSTERIOR AUGMENTS, STEM AND ADAPTOR MBT TIBIA REVISION SIZE 3, WEDGE, STEM SIZE 4 20MM INSERT TC3 RP PATELLA 41MM 3 PEG.

  Patient problems: Joint Laxity

  MAUDE report 16017490 ↗
• InjuryDec 9, 2022Osseointegration Problem; Osseointegration Problem

  FEMALE PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT LOOSENING OF THE TIBIAL CONSTRUCT SECONDARY TO THE CEMENT COMING INTO CONTACT WITH THE TIBIAL SLEEVE PREVENTING APPROPRIATE BONE INGROWTH WITH THE POROUS SURFACE. THERE WAS SIGNIFICANT TIBIAL BONE LOSS. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: 2013. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15952245 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED TKA. REMOVED IMPLANTS THAT WERE IMPLANTED (B)(6) 2020. PERFORMED WASHOUT, I&D AND IMPLANTED A ANTIBIOTIC CEMENT SPACER. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12296881 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY TKA OCCURRED ON (B)(6) 2015 SECONDARY TO ARTHRITIS. IT IS NOTED THAT AN INTRAMEDULLARY NAIL WAS REMOVED AND THERE WAS EVIDENCE OF PATCHES OF AVASCULAR NECROSIS OF BONE AT THE PROXIMAL AND DISTAL FEMUR THOUGH NO INFORMATION PROVIDED AS TO THE MANUFACTURER OF THE INTRAMEDULLARY NAIL OR REASON FOR THE NECROSIS. A DEPUY FEMORAL COMPONENT, ADAPTER BOLT, FEMORAL ADAPTOR, FEMORAL STEM, TIBIAL TRAY, INSERT, PATELLA, AND DEPUY CEMENT X 2 WAS USED AT THE PRIMARY. THE FEMORAL COMPONENT, ADAPTOR, BOLT, STEM, AND INSERT WAS LATER REVISED ON (B)(6) 2016 FOR PAIN AND ASEPTIC LOOSENING. THE OPERATIVE REPORT STATES THAT INTRA-ARTICULAR ADHESIONS WERE LYSED AND THE FEMORAL COMPONENT AS REMOVED WITH EASE REQUIRING A BACK SLAPPING DEVICE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 12123249 ↗
• InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION OF RIGHT TOTAL KNEE TO ADDRESS INFECTION. DATE OF PRIMARY: (B)(6) 2008 (NON-DEPUY PRODUCTS IMPLANTED). DATE OF REVISION #1: (B)(6) 2010 (INSTABILITY - FEMUR, TIBIAL TRAY, TIBIAL INSERT). DATE OF REVISION #2: (B)(6) 2012 (INFECTION - FEMUR, TIBIAL TRAY, TIBIAL INSERT, COMPETITOR PATELLA 12 IPS CAPTURED ON (B)(4) AND (B)(4)). DATE OF REVISION #3: (B)(6) 2013 (12 IPS CAPTURED ON (B)(4) AND (B)(4)) (RIGHT KNEE). TREATMENT: REVISION OF FEMUR CONSTRUCT, TIBIAL TRAY CONSTRUCT, PATELLA, AND TIBIAL INSERT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10837010 ↗
• InjuryDec 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A 2ND RIGHT KNEE REVISION DUE TO LOOSENING OF THE FEMORAL COMPONENT, CHRONIC MEDIAL FEMORAL CONDYLAR FRACTURE, AND MALROTATION OF THE TIBIAL COMPONENT. THE SURGEON NOTED THE PATIENT¿S KNEE GAVE OUT IN (B)(6) OF 2018, CAUSING A FALL. THE SURGEON REPORTED A MEDIAL FEMORAL CONDYLAR FRACTURE WITH SCLEROSIS AND FIBROUS TISSUE IN THE AREA. HE NOTED THE FEMORAL COMPONENT WAS LOOSE, AND FIBROUS TISSUE SURROUNDED THE SLEEVE, AND WAS EXCISED. THE SURGEON REPORTED THE TIBIAL COMPONENT WAS WELL-FIXED. THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED. HE INDICATED THE PATELLAR TRACKING WAS REASONABLE, AND WAS RETAINED. THE PATIENT WAS IMPLANTED WITH DEPUY COMPONENTS AND COMPETITOR BONE CEMENT.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9418437 ↗
• InjurySep 23, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL SLEEVE COMPONENT AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO REPORTED THAT THE FEMORAL SLEEVE COMPONENT BECAME LOOSE DUE TO AN UNKNOWN EVENT. A LARGER SLEEVE AND STEM WERE REIMPLANTED. THERE WAS NO INDICATION FROM THE SURGEON THAT IT WAS A DEFECT OF THE IMPACTS OR THE CEMENT. DOI: (B)(6) 2017; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9106996 ↗
• InjuryOct 15, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  LOOSING OF FEMORAL COMPONENTS POST REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 7967116 ↗
• InjuryNov 14, 2017Loss of Osseointegration; Loss of Osseointegration

  DER STATES PT COMPLAINED OF THIGH PAIN AND INSTABILITY WITH POOR QUAD FUNCTION AND PATELLA TRACKING. INSTABILITY NOTED AT ROUGHLY 20 DEG FLEXION. FROZEN SECTION AND LABS NOT INDICATIVE OF INFECTION. FEMORAL SLEEVE WAS NOT INGROWN AND WAS RE-PREPARED AND REPLACED. TIBIAL AND STEM WERE ALSO REMOVED AND REPLACED, BUT SLEEVE WAS FOUND TO BE INGROWN AND WELL FIXED. A PATELLAR TENDON ALLOGRAFT WAS USED. IT ALSO STATES LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO IMPLANT INTERFACE.

  Patient problems: Pain

  MAUDE report 7029392 ↗
• InjuryOct 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT AN UNKNOWN INTERFACE, CEMENT MANUFACTURER IS UNKNOWN. IT WAS NOTED THAT THE TIBIA WAS WELL FIXED AND LEFT IN PLACE. SURGEON REFUSED TO DISTAL FEMUR REPLACEMENT DUE TO PERFORATION OF STEM THROUGH CANAL AND DISTAL BONE LOSS.

  Patient problems: Bone Fracture(s)

  MAUDE report 6976923 ↗
• InjuryJul 17, 2017Disassembly; Disassembly

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF FEMORAL IMPLANT AT THE CEMENT/BONE INTERFACE AND TIBIAL COMPONENT LOOSENING AT THE AT BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. IT WAS ALSO STATED THAT THE FEMORAL STEM WAS NOT TIGHT ON THE FEMORAL ADAPTER.

  Patient problems: No Information

  MAUDE report 6718790 ↗