ATTUNE 1516-51-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295053132), received between Dec 19, 2019 and Feb 26, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR INFECTION. DOI: (B)(6) 2022, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24455884 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE AN INFECTION. SO, SURGEON PULLED ORIGINAL IMPLANTS AND PUT IN A CEMENT SPACER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21936291 ↗
• MalfunctionFeb 7, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THEY COULD NOT SEE ANY BREAKAGE OR BROKEN SEAL FROM THEIR PERSPECTIVE ¿ IT WAS ODD AS AT FIRST AND THOUGHT THE DIRT WAS ON THE OUTSIDE, BUT THEN IT SEEMED TO HAVE AFFECTED THE WRITING UNDER THE PACKAGING THEREFORE THERE WERE CONCERNS WITHIN THE TEAM THAT STERILITY MAY NOT BE IN TACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659186 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2022; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18629209 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2022 WHERE AN ATTUNE TKR WAS UTILISED (SURGEON, (B)(6) PVT). PATIENT WAS DOING WELL UNTIL POST QUAD TENDON REPAIR 10 WEEKS POST TKR. PATIENT HAS PRESENTED WITH AND INFECTED KNEE. A DECISION WAS MADE TO OPEN THE KNEE AND PERFORM A WASHOUT AND POLY EXCHANGE. (SURGEON, (B)(6) PVT) AT THIS STAGE THERE IS NO DETAIL ON THE BUGS INVOLVED. DEPUY CEMENT WAS NOT UTILISED AT TIME OF PRIMARY SURGERY. PLEASE NOTE REASON FOR LATE SUBMISSION - I WAS AWAITING FEEDBACK FROM SURGEON AS I WAS NOT AT THE CASE AND WAS UNSURE WHAT HAD TRANSPIRED. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? UNKNOWN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. FACILITY NAME OF ORIGINAL IMPLANT: JOHN FLYNN. WAS DEVICE EXPLANTED? TRUE. HARDWARE/EXPLANT REMOVAL DUE TO: INFECTION. DID PATIENT REQUIRE REVISION SURGERY? TRUE. IF YES, DATE OF REVISION SURGERY. 10/21/2022. REASON FOR REVISION SURGERY. INFECTION POST QUAD REPAIR - WASHOUT. PATIENT STATUS/ OUTCOME / CONSEQUENCES. WAS OT

  Patient problems: Unspecified Infection

  MAUDE report 15744926 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, REVISED TO ADDRESS LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, AND PAIN. THE SURGEON REPORTED A LOT OF ADHESION TISSUE AROUND THE PATELLA AND PATELLAR TENDON. HE INDICATED THE KNEE WAS VERY STIFFNESS. THERE WAS NO ADHERENCE AT THE FEMORAL - CEMENT TO IMPLANT INTERFACE. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS COMPLETELY LOOSE AT THE COMPONENT TO CEMENT INTERFACE. HE NOTED THE PATELLA WAS FOUND TO BE PLACED LATERAL AND WITH SOME WEAR, AND REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015 (TIBIAL TRAY, CEMENT, PATELLA AND FEMORAL COMPONENT); DOI: (B)(6) 2016 (TIBIAL INSERT); DOR: (B)(6) 2018 (LEFT KNEE).

  Patient problems: Adhesion(s); Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9497792 ↗