ATTUNE 1516-20-705Recalls & reported problems

Summary

The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10603295045885), received between Sep 20, 2017 and Feb 26, 2026 — classified as 71 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT PRIOR SURGERY IT WAS OBSERVED THAT THERE WAS HOLE IN THE INNER STERILE PACKAGE. ATTUNE CR FB INSRT SZ 7 5MM - 151620705 (LOT: MF0191) (151620705): UNKNOWN ATTUNE CR FB INSRT SZ 7 5MM - 151620705 (LOT: MF0191) (151620705): LOT/BATCH NUMBER: MF0191 LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO WAS THERE A SIGNIFICANT DELAY? NO NO SURGICAL DELAY, NO ADVERSE PATIENT CONSEQUENCES REPORTED WOULD YOU LIKE A RETURN LABEL AT THE END OF THIS PROCESS? NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455534 ↗
• MalfunctionDec 30, 2025Naturally Worn; Appropriate Device Problem Term/Code Not Available; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR LOOSENING OF THE FEMORAL COMPONENT, TIBIAL COMPONENT, AND PAIN. THE ARTICULAR SURFACE SHOWS MINOR YELLOWING AND SEVERE ABRASION AND PITTING.

  Patient problems: Pain

  MAUDE report 23923575 ↗
• MalfunctionOct 23, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE LOCKING MECHANISM WAS FAULTY. WOULD NOT ENGAGE IN TIBIAL TRAY. DOE: (B)(6) 2025. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367841 ↗
• MalfunctionJul 22, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE BEARING WOULD NOT SEAT, THE ITEM WAS WASTED. AFFECTED SIDE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563642 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 22027372 ↗
• InjuryDec 27, 2024Naturally Worn; Naturally Worn

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO WEAR OF THE TIBIAL INSERT AND PATELLA. THE PATELLA WAS ALSO NOTED TO BE LOOSE (UNKNOWN INTERFACE).

  Patient problems: Insufficient Information

  MAUDE report 21026869 ↗
• InjuryNov 19, 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 AND POLY SWAP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20723405 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A DEBRIDEMENT AND POLY EXCHANGE FOR TIGHTNESS. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 20565723 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAP DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20492843 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR ORIGINAL SURGERY DONE ON (B)(6) 2022. PATIENT KNEE IS INFECTED AND SURGEON WOULD LIKE TO PERFORM A THOROUGH WASHOUT OF THE KNEE WITH A POLY EXCHANGE. THE ORIGINAL CR POLY WAS REMOVED, THE KNEE WAS WASHED OUT, AND A NEW POLY WAS INSERTED. STABILITY OF THE KNEE WAS CONFIRMED. THERE WAS NO DELAY. DOI: (B)(6) 2022, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20361771 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20127731 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY SWAP DUE TO INFECTION. DOI:(B)(6) 2024, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20039338 ↗
• InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED RTK. SURGEON WENT IN AND REMOVED ALL 4 TOTAL KNEE COMPONENTS; FEMORAL, TIBIAL, INSERT AND PATELLA COMPONENTS. AFTER AN EXTENSIVE IRRIGATION AND DEBRIDENT, SURGEON CHOOSE TO PUT IN A TEMPORARY HI DOSE ANTIBIOTIC SPACER. THE SPACER COMPONENTS CONSISTED OF AN ATTUNE CR CEMENTED FEM COMPONENT RIGHT AND AN ATTUNE ALL POLY TIBIAL COMPONENT. DOI: (B)(6) 2021 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19219949 ↗
• MalfunctionApr 29, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE FIXED BEARING POLY DID NOT LOCK INTO TIBIAL PLATE SUFFICIENTLY, KEPT LIFTING OFF WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19200977 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 18758423 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION COMPLAINT RECEIVED AD 7 DEC 2023. MEDICAL RECORDS REVIEW (B)(4) MEDICAL RECORDS AD 7 DEC 2023): ON (B)(6) 2015, THE PATIENT RECEIVED AN ATTUNE RIGHT TOTAL KNEE REPLACEMENT, FOR END-STAGE OSTEOARTHRITIS, UTILIZING SIZE 7 FEMUR, SIZE 7 TIBIAL TRAY, SIZE 7 BY 7.5MM THICK INSERT, AND 41MM PATELLA IMPLANTS, WITH COMPETITOR ANTIBIOTIC BONE CEMENT. HE HAD NO COMPLICATIONS. PRIMARY IMPLANTS ON PAGE 8 OF MEDICAL RECORDS. PATIENT PROGRESSED WELL UNTIL HE BEGAN TO EXPERIENCE PERSISTENT PAIN, STIFFNESS, LOCKING AND CHRONIC SWELLING IN (B)(6) 2021. X-RAYS REVEALED LUCENCY BEHIND FEMUR AND TIBIAL COMPONENTS. REVIEW OF HIS BONE SCAN OF THE RIGHT KNEE ON DECEMBER 6, 2012 REVEALED APPARENT LOOSENING OF THE FEMUR COMPONENT. PLANS WERE MADE FOR A REVISION OF THE RIGHT KNEE. RIGHT KNEE WAS REVISED ON (B)(6) 2022, TO ADDRESS PAIN, SWELLING, STIFFNESS, MID-FLEXION AND VARUS-VALGUS JOINT INSTABILITY, AND FEMORAL IMPLANT LOOSENING (AT UNSPECIFIED INTERFACE), WITH REVISION OF THE FEMUR, TIBIAL TRAY, PATELLA AND INSERT COMPONENTS. IT WAS NOTED THAT NEITHER THE FEMUR OR TIBIAL TRAY COMPONENTS REMOVED HAD MUCH IN THE WAY OF ANY CEMENT ADHERED TO THE IMPLANTS, THAT THEY CAME OUT RELATIVELY FREE OF C

  Patient problems: Joint Laxity; Muscular Rigidity; Pain; Swelling/ Edema

  MAUDE report 18380621 ↗
• InjuryDec 12, 2023Naturally Worn; Naturally Worn

  INLAY DEFECT KNEE WAS REVISED TO ADDRESS IMPLANT BEARING WEAR.

  Patient problems: Insufficient Information

  MAUDE report 18310217 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ,THE PATIENT CAME INTO THE ER WITH AN INFECTION IN HIS SPINE AROUND HARDWARE THAT THE HAD AND ALSO HAD A PAINFUL AND SWOLLEN KNEE WITH AN ATTUNE IMPLANT THAT WAS INFECTED. SURGEON WAS UNAWARE WHEN THE PATIENT HAD THEIR KNEE REPLACED, WHO DID THE KNEE REPLACEMENT, OR WHERE THE PATIENT HAD THEIR KNEE REPLACED. DURING THE I&D SURGEON EXPLANTED A SIZE 7X5MM FIXED BEARING INSERT. A NEW SIZE 7X5MM INSERT WAS IMPLANTED AFTER THE I&D WAS COMPLETED. THE FEMORAL, TIBIAL, AND PATELLA COMPONENTS WERE LEFT IN SITU. DOI: UNKNOWN. DOR: (B)(6),2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17731688 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD A PATIENT WITH AN ATTUNE TKA. THAT HE WAS GOING TO WASH OUT AND EXCHANGE THE KNEE INSERT. ACCORDING TO SURGEON THE PATIENT CAME INTO THE ER WITH AN INFECTION IN HIS SPINE AROUND HARDWARE. HE ALSO HAD A PAINFUL AND SWOLLEN KNEE WITH AN ATTUNE IMPLANT THAT WAS INFECTED. DURING THE I&D SURGEON EXPLANTED A SIZE 7X5MM FIXED BEARING INSERT. A NEW SIZE 7X5MM INSERT WAS IMPLANTED AFTER THE I&D WAS COMPLETED. THE FEMORAL, TIBIAL, AND PATELLA COMPONENTS WERE LEFT IN SITU. DOI: UNKNOWN. DOR:(B)(6) 2023. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 17718761 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DAIR FOR SUSPECTED KNEE INFECTION. FULL WASHOUT AND DEBRIDEMENT AND REPLACEMENT OF SIZE 7 5MM CR/FB INSERT COMPLETED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 17661684 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY EXCHANGE FOR INFECTION, ORIGINAL SURGERY (B)(6) 2023, LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17611880 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO RIGHT KNEE INSTABILITY. POLY SWAP TO LARGER SIZE . DOI: ON (B)(6) 2022, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17583572 ↗
• InjuryAug 14, 2023Naturally Worn; Naturally Worn

  PATIENT RECEIVED A LEFT ATTUNE TKA TO TREAT SEVERE ARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 1 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2023: PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT SUSPECTED TIBIA TRAY LOOSENING. UPON ENTERING THE JOINT, METALLOSIS, SYNOVITIS, AND SCAR TISSUE WERE DEBRIDED. THE FEMORAL COMPONENT WAS WELL-FIXED AND ALIGNED BUT REVISED TO ACCOMMODATE THE REVISION CONSTRUCT. THE EXPLANTED TIBIAL INSERT SHOWED SIGNS OF MINIMAL WEAR AND OXIDATION. THE REVISED TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE. THE PATELLA WAS WELL-FIXED WITH SIGNS OF MINIMAL WEAR BUT RETAINED. THE PATIENT RECEIVED A DEPUY ATTUNE REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2014. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Adhesion(s); Foreign Body Reaction; Synovitis

  MAUDE report 17540741 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED KNEE. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17172934 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH POLY WHEN DOING AN I&D OF KNEE DUE TO POSSIBLE INFECTION. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17085912 ↗