ATTUNE 1516-30-906Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295048237), received between Oct 5, 2018 and Jul 14, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO AN INFECTED TKA. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22496947 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT A PRIMARY ATTUNE TKR ON THE (B)(6) 2020. PATIENT EXPERIENCED INSTABILITY APPROXIMATELY TWO WEEKS POST-OP; SURGEON SUSPECTS HE "WENT TOO HARD TOO SOON" AND DAMAGED SOME SOFT TISSUES WHICH CAUSED SOME FLEXION INSTABILITY. INSERT WAS REVISED TO A THICKER ONE AND THE KNEE FELT AND LOOKED STABLE AGAIN ON THE TABLE. IF OTHER, DESCRIBE --> N/A, IF OTHER, DESCRIBE --> TOTAL KNEE REPLACEMENT, DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION? --> YES, IF YES, PLEASE DESCRIBE. --> POST-OP INSTABILITY., 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 --> SJOG MIDLAND, WAS DEVICE EXPLANTED? --> TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: --> INSTABILITY, DID PATIENT REQUIRE REVISION SURGERY? --> TRUE, IF YES, DATE OF REVISION SURGERY. --> (B)(6) 2020, REASON FOR REVISION SURGERY. --> INSTABILITY, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? --> N/A, PATIENT STATUS/ OUTCOME /

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10857391 ↗
• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. POLY EXCHANGE WAS PERFORMED. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9721769 ↗
• InjuryOct 5, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7940334 ↗