ATTUNE 1520-20-806Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295542735), received between Nov 7, 2022 and Sep 29, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 50935451 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT NEEDED TO BE WASHED OUT DUE TO WOUND COMPLICATIONS - SURGEON DECIDED TO DO A FULL WASH OUT AND SWAP POLY WHILE ON THE JOINT. AFFECTED SIDE-RIGHT KNEE.

  Patient problems: Erythema; Insufficient Information; Swelling/ Edema

  MAUDE report 24245435 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL ABOUT A 5-6 WEEKS POST OP AND TORE MULTIPLE SOFT TISSUES IN KNEE. SURGEON WENT BACK IN TO FIX AND WANTED TO REPLACE EXISTING POLY SPACER UPON OPENING JOINT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Tissue Injury

  MAUDE report 23597282 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED TOTAL KNEE POLY EXCHANGE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23468199 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT BECAME UNSTABLE POST TKA. ALL COMPONENTS ARE WELL FIXED, WELL ALIGNED, APPROPRIATELY SIZED WITH AN APPROPRIATE JOINT LINE. A THICKER INSERT WAS PLACED UNEVENTFULLY RESTORING STABILITY. THERE WAS NO DELAY, AND NO PATIENT HARM WAS NOTED. THE SURGEON NOTED NO WEAR PRESENT ON THE IMPLANTS; NO ALLEGATION WAS MADE AGAINST ANY COMPONENTS; THE SURGEON BELIEVES PATIENT HAS SIMPLY STRETCHED OUT OVER TIME SINCE HER PROCEDURE. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21920895 ↗
• InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED INFECTION IN KNEE AND WAS REVISED DUE TO THAT. THERE WAS NO OTHER ISSUE, NO IMPLANT MALFUNCTION, NO LOOSENING, NO OTHER COMPLAINTS. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21766561 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED BECAUSE THEY FELL AND BROKE OPEN THE WOUND. IMPLANTS WERE SHOWING THROUGH THE SKIN. WASHED OUT KNEE REPLACED POLY. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 21081910 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED INSERT TO A THICKER POLY TO STABILIZE THE KNEE. IT WAS UNKNOWN ABOUT SURGICAL DELAY. (B)(6).

  Patient problems: Joint Laxity

  MAUDE report 18283880 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY EXCHANGE DUE TO HEMATOMA. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 18040833 ↗
• MalfunctionNov 7, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LOCKING MECHANISM DID NOT WORK. THERE WAS A SURGICAL DELAY OF 10 MINS. DOE: (B)(6) 2022. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15742858 ↗