ATTUNE 1516-40-907Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295050506), received between Jul 15, 2019 and May 13, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY, NEEDED BIGGER POLY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 25160017 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND UNDERWENT A WASH OUT AND POLY SWAP. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall

  MAUDE report 21308324 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INCREASING PAIN. FULL REVISION WAS PERFORMED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21170959 ↗
• InjuryDec 13, 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 SURGEON SUSPICION OF INSTABILITY/PATIENT DISCOMFORT. DOI: UNKNOWN, DOR: UNKNOWN, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 20926896 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS REVISED AND UPSIZED FOR INSTABILITY. THERE WAS NO HARM TO THE PATIENT, NO DELAYS, AND NO BROKEN INSTRUMENTS. THERE WAS NO CLEAR REASON FOR THE INSTABILITY. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20353358 ↗
• InjurySep 10, 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. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20180657 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 17181353 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2014. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17140529 ↗
• MalfunctionJan 27, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LINER WOULD NOT SEAT FULLY AFTER REMOVING AND TRYING SEVERAL MORE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251984 ↗
• MalfunctionDec 13, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE POLY WOULD NOT SEAT INTO THE TRAY FULLY, AFTER CLEARING THE KNEE OUT OUT OF ANY DEBRIS AND REPOSITIONING IT STILL DID NOT SEAT , OPENED A NEW POLY AND IT WENT RIGHT IN. THERE WAS SURGICAL DELAY OF 10 MINUTES. DOE: (B)(6) 2022; LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15969659 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2022, DOR: (B)(6) 2022 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15847843 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO OSTEOLYSIS AND LOOSENING OF THE FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2017. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Osteolysis

  MAUDE report 15199346 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE I AND D WITH POLY EXCHANGE WAS DONE FOR CONFIRMED INFECTION. THERE WAS NO LOOSENING AND SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15147277 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TKR ATTUNE: (B)(6) HOSPITAL, (B)(6) 2019. PRIMARY IMPLANT DATE: (B)(6) 2019. POLY EXCHANGE. REASON FOR REVISION: MULTI LINER EXCHANGE DUE TO INFECTION. 1 X ATTUNE PS FB INSRT SZ 9 7MM; LOT NO: UNKNOWN - DISCARDED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8789594 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507