ATTUNE 1516-40-607Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10603295050087), received between Aug 25, 2017 and Aug 11, 2026 — classified as 63 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 50215595 ↗
• InjuryJul 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON THINKS THE PATIENT HAD A REACTION TO A MEDICATION THAT WAS GIVEN DURING THE BLOCK BUT WANTED WASH OUT AND CHANGE THE MODULAR COMPONENTS OF THE KNEE TO BE SAFE. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25907379 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SCAR EXCISION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 25018734 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPLANT FOR INFECTION. IMPLANTS DID NOT FAIL. NO LOOSENING. NO INSTABILITY. NO DELAY. NO OTHER INFO KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE:

  Patient problems: Unspecified Infection

  MAUDE report 24926501 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD SOFT TISSUE LAXITY. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24831561 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO SOFT TISSUE LAXITY. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24831503 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO AN INFECTION. THE SURGEON PERFORMED A WASHOUT WITH A POLY SWAP. DOI: (B)(6) 2022, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24473892 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED DUE TO INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24432124 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IRRIGATION AND DEBRIDEMENT OF THE KNEE FOR SUSPECTED INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23498996 ↗
• InjuryOct 23, 2025Naturally Worn; Naturally Worn

  PATIENT UNDERWENT REVISION SURGERY DUE TO TIBIAL ASEPTIC LOOSENING AT THE CEMENT/IMPLANT INTERFACE. LEFT TIBIA, CEMENT NOT FROM DEPUY. PATIENT HAD EXPERIENCED PAIN. DOR: (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 23367478 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND BROKE SKIN TO KNEE. KNEE INFECTION CONFIRMED WITH ASPIRATION. THIS EVENT DID NOT EXTEND SURGERY TIME OR HAVE ANY ADVERSE EVENTS ON OUR PART. THERE IS NO LOT NUMBER AVAILABLE. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 22586681 ↗
• MalfunctionJun 25, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INTRAOPERATIVELY IT WAS NOT POSSIBLE TO ENGAGE THE INLAY WITH THE TIBIAL TRAY. ANOTHER INLAY WAS AVAILABLE AND USED WITHOUT ANY ISSUE. NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328633 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS LACKING EXTENSION SO THE SURGEON UPSIZED THE POLY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22107870 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SLIGHT PAIN, THEREFORE INCREASED POLY 7 TO 10. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22069410 ↗
• InjuryMay 13, 2025Adverse 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 PAIN. IMPLANT DATE WAS AN UNKNOWN DATE IN IN 2013. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22010389 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED LAXITY IN HER KNEE AFTER SIGNIFICANT WEIGHT LOSS. ALL COMPONENTS WERE WELL SIZED AND WELL FIXED WITH APPROPRIATE ALIGNMENT AND JOINT LINE. THE INSERT WAS REMOVED AND NO WEAR WAS NOTED. A THICKER INSERT IS TRIALED AND STABILITY WAS FOUND TO BE RESTORED AND ROM WAS APPROPRIATE. THERE WAS NO DELAY AND NO PATIENT HARM WAS NOTED. IMPLANT INFORMATION (LOT) WAS NOT CAPTURED IN THE MIGRATION FROM COMPASS TO OPTIMIZE AND THUS IS NOT AVAILABLE. THE SIZE OF THE COMPONENT WAS FOUND BY EXAMINING THE INSERT ONCE REMOVED OPERATIVELY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21687697 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DSJ_2016_02; CLINICAL ADVERSE EVENTS RECEIVED FOR FOLLOWING A PERIOD OF EXTENDED CROUCHING, HAS EXPERIENCED A TENDER POINT MID RIGHT SHIN AND A PAINFUL RIGHT KNEE DEVICE AND PROCEDURE(RELATEDNESS) RELATEDNESS TO DEVICE: POSSIBLY RELATEDNESS TO PROCEDURE: POSSIBLY DATE OF EVENT: UN OCT 2023 DATE OF IMPLANT: (B)(6) 2020 DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: RIGHT TREATMENT/IMPACT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 21295909 ↗
• InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POLY SWAP FOR POTENTIAL INFECTION. DOI: (B)(6) 2024. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20148676 ↗
• InjuryJul 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 19782084 ↗
• MalfunctionJun 25, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE ATTUNE SIZE 6, 7MM PS FIXED BEARING INSERT WOULD NOT PROPERLY SEAT OR LOCK INTO BASEPLATE, WHICH WAS A SIZE 5 A TUNE BEARING BASEPLATE WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? OPENED THE SAME SIZE DIFFERENT LOT, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607498 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MRR FINDINGS RECEIVED. IT WAS CONFIRMED THAT THE PATIENT WAS REVISED DUE TO ADDRESS TIBIAL ASEPTIC LOOSENING AND PAIN. THERE WAS A COMPLETE DEBONDING OF THE TIBIAL TRAY TO THE CEMENT MANTLE. DOI: (B)(6) 2016. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 19096381 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: CLINICAL ADVERSE EVENT RECEIVED FOR TENDER POINT MID RIGHT SHIN AND PAINFUL RIGHT KNEE. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: (B)(6) 2023 (RIGHT KNEE). TREATMENT: INJECTED MEDICATION.

  Patient problems: Discomfort; Pain

  MAUDE report 18825524 ↗
• MalfunctionNov 7, 2023Difficult to Insert; Difficult to Insert

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS STATED THAT: A. THE INSERT DID NOT CONNECT WITH THE TIBIA PLATE AND IT WAS CRUSHED; B. THERE WAS NO SURGICAL DELAY AND THERE WAS NO PATIENT HARM; C. THE UNLOCK OF THE INSERT HAPPENED INTRA-OP. DURING THE SURGERY IT WAS REPLACED WITH AN ADDITIONAL PRODUCT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18082654 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO POLY LINER FOR INSTABILITY. NO OTHER INFORMATION IS KNOWN. DOI: NOV 18, 2021. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17623812 ↗
• InjuryJul 27, 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: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17404470 ↗

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