ATTUNE 1516-50-905Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295052982), received between Jun 20, 2019 and Aug 18, 2026 — classified as 34 injuries.

The most frequently reported specific device problem is “Fracture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50300027 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had poly swap for suspected infection No way to confirm.DOI- (b)(6) 2019.DOR- (b)(6) 2026.Affected side- Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50226882 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SECOND LINER EXCHANGE WASH OUT. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24364694 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD KNEE JOINT INFECTION. INSERT WAS EXCHANGED, KNEE WASHED OUT AND ANTIBIOTICS PLACED. THERE WAS NO PATIENT INJURY OR DELAY. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24315932 ↗
• InjuryJan 27, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO SECOND LINER EXCHANGE WASHOUT. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24189396 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY. INSTABILITY IS NOT RELATED TO POLY WEAR. NO ADDITIONAL INFORMATION AVAILABLE FOR REPORTING. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23767889 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A SEPTIC MOBILIZATION OF RIGHT KNEE. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22204535 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS KNEE WAS EXTREMELY STIFF WITH LIMITED MOTION FROM 15 TO 80 DEGREES. AFTER THE INITIAL TOTAL KNEE SURGERY THE PATIENT WAS NON COMPLIANT WHICH CREATED THE EXCESSIVE SCAR TISSUE BUILD UP. SURGEON REMOVED POLY, 5MM THICKNESS AND DEBRIDED THE KNEE WHICH ALLOWED FOR MOTION FROM 5 TO 100 DEGREES WHICH THE SURGEON WAS SATISFIED WITH. NEW POLY WAS IMPLANTED AND KNEE CLOSED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Loss of Range of Motion; Muscular Rigidity

  MAUDE report 21625844 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER UPSIZED WHILE RELEASING THE IT BAND. THE SURGEON PERFORMED THE UPSIZE BECAUSE THE SURGEON DEEMED IT NECESSARY DUE TO STABILITY. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES. DOI- (B)(6) 2022, DOR- (B)(6) 2024, AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20911831 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT I&D POLY SWAP WAS PERFORMED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20761555 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT HIS KNEE WAS NOT GETTING ENOUGH FLEXION OR FULL EXTENSION. SURGEON REMOVED THE TIBIA, RESECTED MORE PROX TIBIA AND REIMPLANTED. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 20521550 ↗
• InjuryJul 26, 2024Fracture; Fracture

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q2 OF 2024. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISON DUE TO PAIN AND OTHER. AT REVISION THE INSERT SHOWED CRACKING TO THE RIM.

  Patient problems: Pain

  MAUDE report 19840707 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY AFTER A FALL. THE SURGEON REMOVED A SZ9 5MM POLY AND REPLACED WITH A SZ9 10MM POLY. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: JAN 8, 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 18519369 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: -I DON¿T BELIEVE THE TIBIAL COMPONENT WAS LOOSE BUT IT WAS A LARGER MALE AND A DIFFICULT TO GET TO A POSITION TO EVEN HIT THE TRAY TO REMOVE. IF IT WAS LOOSE IT WAS FROM CEMENT TO BONE SINCE THE TRAY STILL HAD CEMENT OF IT. THEY USE GMV DEPUY CEMENT AND WOULD NOT KNOW THE LOT # SINCE THE BUY THE CEMENT DIRECTLY. THEY MIX IN PRISM 2 CARTRIDGE UNDER PRESSURE AND APPLY WITH A CEMENT GUN. THEY APPLY CEMENT TO THE TRAY FIRST ON THE BACK TABLE AND ALSO AFTER CLEANING BONE APPLY MORE CEMENT TO THE BONE SURFACE. THEY USUALLY MIX CEMENT FOR AROUND A MINUTE AND HALF AND START APPLYING AS SOON AS ITS READY.

  Patient problems: Discomfort

  MAUDE report 17878240 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME TO SEE THE SURGEON WITH COMPLAINTS OF INSTABILITY IN HIS LEFT KNEE. THE SURGEON RECOMMENDED A POLY SWAP TO HELP WITH THE INSTABILITY AND HE WAS ABLE TO REMOVE THE POLY (9X5), UPSIZE (9X8) AND BALANCE THE KNEE. DOI: (B)(6) 2016 AND DOR: (B)(6) 2023 AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17816098 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION AND POLY WAS EXCHANGED FOR UNKNOWN BUG. DOI: (B)(6), 2022. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16844019 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS REVISED DUE TO POSSIBLE INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15378577 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. SURGEON WASHED OUT KNEE AND SWITCHED THE POLY INSERT. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15249535 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO AN INFECTION AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. THE FEMUR, TIBIA, AND THE POLY WERE REMOVED. DEPUY CEMENT WAS USED. NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15041127 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT ORIGINAL SURGERY WAS ON (B)(6) 2017. SAME YEAR ON (B)(6) 2017, HAD AN I&D FOR A POSSIBLE INFECTION. AT THAT TIME, THE SAME SIZE INSERT WAS PUT IN FROM THE ORIGINAL SURGERY. TODAY, THE PATIENT WAS SCHEDULED FOR A POLY EXCHANGE DUE TO INSTABILITY. TRIAL INSERTS WERE USED AND A DECISION WAS MADE TO INCREASE THE THICKNESS. STABILITY WAS ACHIEVED WITH AN 8MM INSERT TRIAL. DOI: (B)(6), 2017. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13261873 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LACKED MOTION IN EXTENSION AND FLEXION. WE REMOVED A WELL FIXED TIBIA, RESECTED MORE PROXIMAL TIBIA BONE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 12892322 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS GROSS LOOSENING OF BOTH FEMUR AND TRAY AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. POSITIVE INFECTION PRESENT SO ALL IMPLANTS EXPLANTED AND ANTIBIOTIC SPACER WAS IMPLANTED. UNKNOWN BONE CEMENT WAS USED. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

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

  MAUDE report 12089669 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED PRIMARY ATTUNE TKAS TO TREAT END-STAGE DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN SECONDARY TO ASEPTIC LOOSENING. UPON ENTERING THE JOINT, FEMORAL OSTEOLYSIS WAS IDENTIFIED. THE FEMORAL COMPONENT WAS LOOSENED AT AN UNKNOWN INTERFACE AND REVISED. THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE LOOSENED PATELLA ¿JUST FELL OFF¿ AND WAS REVISED. THE LOOSENED INTERFACE OF THE PATELLAR BUTTON WAS NOT PROVIDED. THE PATIENT WAS REVISED WITH A COMPETITOR REVISION KNEE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: Osteolysis; Pain

  MAUDE report 11673302 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. EXPLANT OF IMPLANTS AND INSERTED ANTIBIOTIC SPACER. NO ADDITIONAL INFORMATION AVAILABLE. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT KNEE.

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

  MAUDE report 10959893 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT KNEE. POLY EXCHANGE WAS DONE. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10857457 ↗