ATTUNE 1516-50-407Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10603295052302), received between Nov 12, 2017 and Nov 25, 2025 — classified as 35 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA AND INSERT REVISED DUE TO INSTABILITY AND PAIN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23645626 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST TKA AND OPENED WOUND. SURGEON DID I&D WITH POLY SWAP. THERE WERE NO ALLEGATIONS AGAINST THE IMPLANT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 22922269 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A STIFF KNEE WITH LOW ROM AND THE IMPLANTS WERE WELL FIXED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 21210134 ↗
• InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION WITH A POLY SWAP DUE TO INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2022; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20543583 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BEING REVISED DUE TO PAIN AND STIFFNESS IN THE LEFT KNEE. IT WAS DETERMINED THE IMPLANTS WERE PUT IN SLIGHT VALGUS ALIGNMENT AND THE FEMORAL COMPONENT HAD AN AREA OF LOOSENING. BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER UNKNOWN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN; DOR- (B)(6) 2024; AFFECTED SIDE- LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18596464 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON SAID THE PATIENT KNEE WAS INFECTED AND DECIDED TO REMOVE IMPLANTED COMPONENTS AND REPLACE WITH CEMENT SPACER. NO ONE REPORTED ANY PROBLEM WITH DEPUY IMPLANTS. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18011690 ↗
• InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN (NON-PERSISTENT). EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE). TREATMENT: NONE.

  Patient problems: Pain

  MAUDE report 16063001 ↗
• InjuryAug 15, 2022Unintended Movement; Unintended Movement

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT FREQUENT DISLOCATIONS OCCURRED AFTER THE MANUAL REDUCTION. THIS PC REPORTS THAT THE POSTERIOR DISLOCATION OCCURRED DUE TO FALL. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE ATTUNE FOR THE OSTEOARTHRITIS OF THE KNEE JOINT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT FELL, AND POSTERIOR DISLOCATION OCCURRED IN (B)(6) 2022. THE SURGEON PERFORMED MANUAL REDUCTION AND USED A BRACE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall

  MAUDE report 15224248 ↗
• InjuryAug 9, 2022Unintended Movement; Unintended Movement

  THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT THE POSTERIOR DISLOCATION OCCURRED DUE TO FALL. THIS PC REPORTS THAT FREQUENT DISLOCATIONS OCCURRED AFTER THE MANUAL REDUCTION. IT WAS REPORTED THAT ON UNKNOWN DATE IN (B)(6) 2022, THE PATIENT UNDERWENT MANUAL REDUCTION DUE TO POSTERIOR DISLOCATION CAUSED BY A FALL. HOWEVER, FREQUENT DISLOCATION OCCURRED. ON (B)(6) 2022, THE SURGEON REMOVED ALL THE IMPLANTS AND INSERTED THE ATTUNE CRS, THE ATTUNE FB. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Fall; Insufficient Information; Joint Laxity

  MAUDE report 15190922 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A RIGHT TOTAL ATTUNE KNEE THAT IS STIFF WITH LIMITED MOTION. THE SURGEON DID AN I&D WITH AN EXCHANGE TO A THINNER TIBIAL INSERT. ALL COMPONENTS ARE WELL FIXED AND RETAINED. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 15048577 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14592541 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO KNEE BEING UNSTABLE IN EXTENSION. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 14039880 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SUFFERED A FALL, RESULTING IN THE REOPENING OF THE INCISION. REVISION WAS COMPLETED. INSERT WAS EXCHANGED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 13550116 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S WOUND HAD OPENED UP AFTER A FALL. THE SURGEON WANTED TO WASH HER OUT AND CHANGE THE POLY LINER. THERE WAS NO SUGGESTION OF ANY PROBLEM WITH OUR IMPLANT, NOR ANY CAUSE OF HER ISSUE. NOTHING BROKE OR EXTENDED THE SURGERY TIME. IT WAS JUST A WASHOUT AND POLY EXCHANGE OF A WELL POSITION TKA. DOI: (B)(6) 2021; DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 13190215 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNSTABLE KNEE. THE SURGEON REMOVED THE INSERT AND DID A DEBRIDEMENT WITH AN INSERT EXCHANGE TO A 12MM. THE KNEE WAS STABLE AT THE END OF PROCEDURE. DOI: (B)(6) 2020, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12829584 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS ARTHROFIBROSIS WITH PATELLAR RESURFACING. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2020, DOR: (B)(6), 2021, LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12532149 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING INCREASING PAIN. TIBIA WAS SUSPECTED TO BE LOOSE, IT CAME OUT WITH ONLY A MODERATE TAP TO THE FRONT UNDERSIDE EDGE. TIBIAL REVISION AND POLY EXCHANGE WAS PERFORMED. FEMUR AND PATELLA REMAIN INSITU. DOI: (B)(6) 2014. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12391893 ↗
• InjuryAug 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY. AFTER THE SURGERY, RECURRENT POSTERIOR DISLOCATION OCCURRED. THE REVISION SURGERY WAS PERFORMED BECAUSE OF THE RECURRENT DISLOCATION. DOI: (B)(6) 2019, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 12364721 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY OPERATIVE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REPLACEMENT DUE TO END STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND COMPETITOR CEMENT WAS UTILIZED. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2020 INDICATE THE PATIENT RECEIVED A RIGHT TOTAL KNEE REVISION DUE TO PAIN AND LIMITED RANGE OF MOTION. LOOSENING WAS SUSPECTED PRE-OP BUT WAS NOT CONFIRMED INTRA-OPERATIVELY. UPON ENTERING THE JOINT ADHESIONS AND SYNOVITIS WAS ENCOUNTERED AND REMOVED. ALL IMPLANTS WITH THE EXCEPTION OF THE PATELLA WERE REMOVED WITHOUT NOTED DEFICIENCY. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. DOI: (B)(6) 2016; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Pain; Synovitis

  MAUDE report 12017372 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A FALL AND A RUPTURED INCISION. THE SURGEON DID A WASHOUT AND A POLY CHANGE. DOI: (B)(6) 2021 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 11844843 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A LEFT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO ADDRESS INSTABILITY AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE SURGEON NOTED THE RESECTION OF EXTENSIVE SCAR TISSUE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLAR COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. DOI: (B)(6) 2015 DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Adhesion(s); Joint Laxity

  MAUDE report 11755662 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT ACHILLES' TENDON RUPTURE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE ADVERSE EVENT IS RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF EVENT (ONSET): (B)(6) 2020; (LEFT KNEE).

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11659683 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015 THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS OF THE RIGHT KNEE. DUE TO PATIENT¿S POOR BONE STOCK, PINS IN THE DISTAL FEMUR AND IN PROXIMAL TIBIA WERE NOT SATISFACTORY SO THE PLANS FOR COMPUTER ASSISTED SURGERY WERE ABANDONED. DEPUY COMPONENTS, INCLUDING DEPUY PATELLA AND DEPUY CEMENT X1 WERE IMPLANTED DURING THIS PROCEDURE. THERE WERE NO INTRAOPERATIVE COMPLICATIONS NOTED. (STICKER PAGE 7 OF 12). ON (B)(6) 2018, THE PATIENT HAD A REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY TO ADDRESS FAILED TOTAL RIGHT KNEE. DURING THE PROCEDURE THE SURGEON OBSERVED HYPERTROPHIC SYNOVIAL TISSUE, GROSS LOOSENING OF THE TIBIAL COMPONENT ALONG WITH SUBSIDENCE. THE LOOSENING OF THE TIBIAL TRAY WAS AT THE IMPLANT/CEMENT INTERFACE. THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE (NO INTERFACE), VARUS MALALIGNMENT AND OSTEOLYTIC AREA OF BONE. THE PATELLA WAS NOT REVISED. DEPUY COMPONENTS, INCLUDING DEPUY CEMENT X2 WERE IMPLANTED DURING THIS PROCEDURE. (PART/LOT PAGE 12 OF 12). DOI: (B)(6) 2015 DOR: (B)(6) 2018 (RIGHT KNEE).

  Patient problems: Local Reaction; Osteolysis; Pain

  MAUDE report 11618500 ↗
• InjuryOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED TOTAL KNEE JOINT REPLACEMENT, SURGICAL WASHOUT AND POLYETHYLENE REPLACEMENT.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10679672 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2017 VIA TKA FOR THE PATIENT¿S LEFT KNEE JOINT. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE TIBIAL INSERT (P/N: 151650407) AND IRRIGATING DUE TO INFECTION. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10134729 ↗