ATTUNE 1516-20-605Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 10603295045762), received between Oct 9, 2017 and Jun 3, 2026 — classified as 87 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (7 reports).

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 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD PAIN/INSTABILITY AND RADIOLUCENT LINES AROUND IMPLANTS. SURGEON DECIDED TO REVISE FEMUR AND TIBIA. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE

  Patient problems: Joint Laxity; Pain

  MAUDE report 25381937 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POLY WAS EXCHANGED FOR THICKER INSERT. DOCTOR REMOVED POLY AND PUT IN THICKER POLY, DOCTOR FELT IT WAS A LITTLE TOO LOOSE. DOI: UNKNOWN . DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24911533 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY WAS EXCHANGED FOR INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24209827 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A 5X6 CRS INSERT WAS PUT IN, ON (B)(6) 2022 A 5X5PSRP INSERT WAS PUT IN. PATIENT IS VERY STIFF, PATIENT HAS REQUESTED THE DOCTOR TO TRY ANYTHING CAN TO MAKE KNEE MOVE. DOCTOR BELIEVES THE ONLY THING CAN OFFER IS TO CONVERT THIS REV KNEE TO A HINGE, AND REQUESTED ATTUNE REV HINGE SYSTEM. DOCTOR DOES NOT HAVE TO REMOVE THE WELL FIXED SLEEVE IN THE FEMUR. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 23017647 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PERCEIVED INSTABILITY IN LEFT KNEE. THERE WAS NO SURGICAL DELAY. ACTIVITY LEVEL - YES. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22520970 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A RECURRENT EFFUSION. SURGEON CHOSE TO PERFORM AN I&D AND POLY EXCHANGE WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS. SPECIMENS WERE SENT TO FOR CULTURE. PRIOR ASPIRATIONS HAVE NOT BEEN POSITIVE FOR INFECTION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22339245 ↗
• InjuryJun 24, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF ATTUNE PROTHESIS. THE INSERT WAS REMOVED AND APPEARED VERY WORN AND FEMUR WAS LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 22323887 ↗
• MalfunctionJun 11, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY. SURGEON HAD TROUBLE INSERTING DEFINITIVE INSERT AND CLAIMED THAT THE LOCKING MECHANISM WAS FAULTY. THERE WAS A SURGICAL DELAY. OF 10 MINUTES. A NEW INSERT WAS OPENED AND INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186975 ↗
• InjuryJun 5, 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 INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22153402 ↗
• InjuryNov 25, 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 PAIN. DOI: UNK. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20775956 ↗
• MalfunctionOct 14, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT ON APR. 17, 2024, THE COLOR OF THE SIZE INDICATOR ON THE PACKAGE OF THE PRODUCT IN QUESTION DIFFERED FROM THE STANDARD PRODUCT VERSION. (STANDARD PRODUCT: YELLOW, SAID PRODUCT: PINK). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438613 ↗
• MalfunctionOct 14, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT ON (B)(6) 2024 , THE COLOR OF THE SIZE INDICATOR ON THE PACKAGE OF THE PRODUCT IN QUESTION DIFFERED FROM THE STANDARD PRODUCT VERSION. (STANDARD PRODUCT: YELLOW, SAID PRODUCT: PINK). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438612 ↗
• MalfunctionOct 14, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT ON (B)(6) 2024, THE COLOR OF THE SIZE INDICATOR ON THE PACKAGE OF THE PRODUCT IN QUESTION DIFFERED FROM THE STANDARD PRODUCT VERSION. (STANDARD PRODUCT: YELLOW, SAID PRODUCT: PINK). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438611 ↗
• MalfunctionOct 14, 2024Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT ON (B)(6) 2024, THE COLOR OF THE SIZE INDICATOR ON THE PACKAGE OF THE PRODUCT IN QUESTION DIFFERED FROM THE STANDARD PRODUCT VERSION. (STANDARD PRODUCT: YELLOW, SAID PRODUCT: PINK). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438610 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19844736 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FROM 5MM CR INSERT TO 10MM MS LEFT INSERT DUE TO INSTABILITY. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19541900 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR PAIN IN LEFT KNEE- ASPIRATION. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2013. DATE OF EVENT: 13 FEB 2014. (LEFT KNEE). TREATMENT: MEDICAL INTERVENTION/MODIFICATION.

  Patient problems: Pain

  MAUDE report 19221707 ↗
• MalfunctionApr 30, 2024Wrong Label; Wrong Label

  IT WAS REPORTED THAT ON APR. 16, 2024, THE COLOR OF THE SIZE INDICATOR ON THE PACKAGE OF THE PRODUCT IN QUESTION DIFFERED FROM THE STANDARD PRODUCT VERSION. (STANDARD PRODUCT: YELLOW, SAID PRODUCT: PINK). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19211730 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: PAIN.

  Patient problems: Pain

  MAUDE report 18967532 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO LOOSE IN FLEXION AND EXTENSION. SURGEON USED A 10MM CR MS POLY. DOI: UNKNOWN. DOR: (B)(4) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 18761693 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REVISED. THE REASON FOR REVISION WAS INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 18746759 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED KNEE REVISION SURGERY. THIS WAS DUE TO FAILURE OF PRIMARY ATTUNE IMPLANTS IN SITU. DOI: (B)(6) 2017. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18383205 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH I&D AND POLY EXCHANGE DUE TO POSSIBLE INFECTION. SURGICAL DELAY UNKNOWN. ACTIVITY LEVEL - YES. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18257614 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IRRIGATION AND DEBRIDEMENT (I&D) WITH A POLY EXCHANGE DUE TO POSSIBLE INFECTION. DOI: (B)(6), 2021. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18235938 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR HAD A PATIENT PRESENT WITH A SUSPECTED RTK INFECTION. THE SURGEON ELECTED TO PREFORM A ONE STAGE I&D WITH A POLY SWAP. THE OTHER COMPONENTS, FEMUR, TIBIA, AND PATELLA WERE WELL FIXED AND POSITIONED APPROPRIATELY. ONCE THE I&D WAS DONE A NEW INSERT OF THE SAME SIZE WAS THEN INSERTED AND SNAPPED ONTO THE TIBIAL TRAY. THE PATENT CLOSED IN THE USUAL FASHION. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18129671 ↗