ATTUNE 1516-50-806Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10603295052852), received between Apr 12, 2018 and Sep 11, 2026 — classified as 54 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that there was pain. It did not happen in surgery. DOE: (b)(6) 2026.Affected Side: Left Knee.

  Patient problems: Pain

  MAUDE report 50736932 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS EXCHANGED FOR INFECTION. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25015566 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD INCREASING ANTERIOR KNEE PAIN AFTER A RIGHT TKA. THE PATELLA WAS ORIGINALLY NOT RESURFACED AND THE SURGEON RESURFACED IT. THEY ALSO EXCHANGED THE POLY INSERT FOR A NEW ONE WHILE HE WAS AT IT. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 23851964 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE MANUFACTURER OF THE 1ST LINER? IS IT FROM DEPUY? - YES.

  Patient problems: Unspecified Infection

  MAUDE report 23826881 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS INFECTION. THE KNEE WAS WASHED OUT, ANTIBIOTICS WERE PLACED AND INSERT WAS EXCHANGED. NO DELAYS WERE REPORTED. DOI: (B)(6) 2014. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23803875 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN INITIAL SURGERY FOR KNEE WITH THE PRODUCT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2025, THE SALES REP WAS INFORMED THAT THE DEBRIDEMENT DUE TO INFECTION IS SCHEDULED FOR (B)(6) 2025, AND THE INSERT IS ALSO SCHEDULED TO BE REPLACED. ON (B)(6) 2025, DEBRIDEMENT AND INSERT REPLACEMENT WERE PERFORMED DUE TO INFECTION. AFTER REMOVING THE PSRP INSERT NO. 8, 6 MM, IT WAS REPLACED WITH THE SAME PRODUCT. THE DIAGNOSIS WAS LEFT SEPTIC ARTHRITIS.

  Patient problems: Arthritis; Unspecified Infection

  MAUDE report 23349385 ↗
• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I&D POLY EXCHANGE. NEW ONSET INFECTION FROM LEG SORES. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22132604 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD I&D AND POLY SWAP. UNABLE TO DETERMINE INFECTION. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21860746 ↗
• MalfunctionMar 14, 2025Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT BEFORE THE SURGERY, THE OUTER PACKAGING WAS FOUND TO BE DAMAGED - THE SEAL WAS LEAKY, AND THE STERILE ENVIRONMENT OF THE PROSTHESIS WAS COMPROMISED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604331 ↗
• InjuryNov 25, 2024Adverse 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 POSSIBLE INFECTION. PULLED ORIGINAL POLY AND REPLACED WITH NEW POLY OF SAME SIZE. DOI; (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20772835 ↗
• InjuryOct 15, 2024Adverse 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 INFECTION AND IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20453383 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY NO CEMENT REVISED.

  Patient problems: Pain

  MAUDE report 19702401 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INCREASING PAIN AND INSTABILITY AND PATELLA AND TIBIAL REVISION WAS PERFORMED. THE TIBIA WAS LOOSE AT THE CEMENT/IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2015. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18596766 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: JAN 12, 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18527162 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM ALES REP: NO SURGICAL DELAY. NO INSTABILITY. NO MALPOSITION. NO INSTABILITY. NO MALPOSITION- ROTATION OR OTHERWISE. PATIENT FAILED TO FOLLOW POSTED POST-OPERATIVE PHYSICAL THERAPY PROTOCOLS SET FORTH BY SURGEON, THUS REQUIRING REVISION SURGERY.

  Patient problems: Adhesion(s); Muscular Rigidity

  MAUDE report 18365136 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INFECTION SURGEON DID A IRRIGATION AND DEBRIDEMENT (I&D) AND POLY SWAP. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- UNKNOWN. DOR- (B)(4), 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18276707 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR SLIGHT GAIT INSTABILITY LEFT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2019. DATE OF EVENT: UNKNOWN IN 2023. (LEFT KNEE). TREATMENT: RECOMMENDATION FOR KNEE CONTROL IN THE ORTHOPEDIC DEPARTMENT . DEPUY PRODUCTS USED (NO REVISION COMPLETED):

  Patient problems: Joint Laxity

  MAUDE report 17773518 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17360768 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED KNEE. SURESPACE ARTICULATING SPACER MOLD WAS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16938201 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D POLY EXCHANGE FOR INFECTION. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16466716 ↗
• InjuryFeb 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON THOUGHT THAT THE PATIENT'S KNEE PAIN WAS COMING FROM A LOOSE FEMORAL IMPLANT. AFTER REMOVING THE POLY INSERT, IT WAS DETERMINED THAT THE FEMUR WAS SOLID. THE KNEE JOINT WAS THEN DEBRIDED AND A NEW SZ8 6MM POLY WAS INSERTED AND THE WOUND WAS CLOSED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16301866 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN. HIS TIBIA WAS POSSIBLY LOOSE BUT INCONCLUSIVE. SURGEON CONDUCTED A FULL EXPLANT AND REVISION. THE LOOSENING INTERFACE IS AT THE CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2018, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16271008 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC EFFUSIONS. NO LOOSENING AND NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Swelling/ Edema

  MAUDE report 16132782 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME STIFF IN FLEXION. THE SURGEON DOWNSIZED THE FEMUR AND DECREASED THE POLY SIZE. ALL LIGAMENTS WERE INTACT. ALL COMPONENTS WERE WELL FIXED. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2020, DOR- (B)(6) 2022, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 16094983 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTED KNEE. I&D AND LINER WERE EXCHANGE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15925762 ↗