ATTUNE 1504-10-206Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 10603295041771), received between Jul 13, 2017 and Sep 29, 2026 — classified as 137 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (16 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 138 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Unspecified Infection

  MAUDE report 50935143 ↗
• 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 INFORMATION KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 24926864 ↗
• InjuryApr 2, 2026Loss of or Failure to Bond

  IT WAS REPORTED THERE WAS FEMORAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2020. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24767070 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  REIMPLANTATION FOLLOWING ARTICULATING SPACER FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24649515 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT COMPLAINED OF PAINFUL TKA. BOTH IMPLANTS WERE WELL FIXED. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 24369528 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SOFT TISSUE INFLAMMATION. THERE WAS LOOSENING OF FEMUR AND TIBIA AT BONE TO CEMENT INTERFACE. COMPONENTS REMOVED AND REVISION COMPONENTS REPLACED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24036430 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23959662 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FEMUR WAS REVISED DUE TO TIGHT IN EXTENSION. THERE WAS NO DELAY, ALL PIECES RETRIEVED, NO ADDITIONAL INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 23789516 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23547283 ↗
• InjuryAug 26, 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 PREVIOUS INFECTION AND UNEXPLAINED PAIN. A POLY EXCHANGED WAS PERFORMED. A FULL REVISION WAS DONE AND FULL DEBRIDEMENT PERFORMED PRIOR TO IMPLANTATION. DOI: UNKNOWN. DOR: (B)(6) 2025 . AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22897417 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INSTABILITY AND THE TIBIAL TRAY WAS LOOSE. CEMENT WAS STILL ON THE BOTTOM OF THE TRAY, SO IT LOOKED TO BE FROM THE CEMENT BONE INTERFACE. REVISION WAS PERFORMED. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21874646 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO AN INFECTION. ALL PARTS WERE REMOVED AND A CEMENT SPACER WAS PLACED. DATE OF THE ORIGINAL PRIMARY SURGERY WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21438089 ↗
• InjuryFeb 18, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAD A VERY LARGE LEG DUE TO LYMPH OEDEMA AND WAS IMPLANTED WITH ATTUNE PS/RP. PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF ALL COMPONENTS. AFFECTED SIDE: RIGHT KNEE

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

  MAUDE report 21403733 ↗
• InjuryJan 8, 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 KNEE PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2023, DOR: (B)(6) 2024, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21102589 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE FEMORAL REVISION FOR FLEXION INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20710574 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOI: (B)(6) 2018: 60-YEAR-OLD FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2022: 65-YEAR-OLD FEMALE PATIENT RECEIVED A TOTAL RIGHT KNEE REVISION TO TREAT PAIN, GROSS INSTABILITY, AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED EXTENSIVE SCAR TISSUE. THE TIBIAL TRAY WAS LOOSE AT AN UNKNOWN INTERFACE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED DUE TO FEMORAL BONE LOSS. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT AND PATELLA. THE PATIENT RECEIVED AND UNKNOWN REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2018, DOR: (B)(6) 2022, RIGHT KNEE4.

  Patient problems: Adhesion(s); Joint Laxity; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 20622908 ↗
• InjuryAug 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AND FEMUR COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. THE CEMENT MANUFACTURER WAS UNKNOWN. NO DELAYS, NO PATIENT HARM, NO BROKEN INSTRUMENT. DATE OF PRIMARY SURGERY UNKNOWN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 20064124 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED AND THE DEVICE WAS EXPLANTED AND SPACER WAS PLACED DUE TO SUSPECTED INFECTION. THERE WAS NO WAY TO CONFIRM THE INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19817161 ↗
• InjuryMay 17, 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 KNEE PAIN. DOI: (B)(6) 2016. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19341560 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN & INSTABILITY. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2021, DOR- (B)(6) 2024, AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19271640 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CONTINUED TO EXPERIENCE PAIN AND INSTABILITY IN HIS KNEE REPLACEMENT AND SURGEON CHOOSE TO DO A KNEE REVISION TO ADDRESS. INITIAL SURGERY WAS ON (B)(6) 2022. A THICKER INSERT WAS PLACED ON (B)(6) 2023 AND A DER WAS SUBMITTED. ALL COMPONENTS WERE WELL FIXED, WELL ALIGNED, APPROPRIATELY SIZED AND WERE REMOVED ON (B)(6) 2024. JOINT LINE ALSO APPEARS APPROPRIATE. NO DELAYS NOR PATIENT HARM WAS EVIDENT. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE. (B)(4), WAS CREATED TO CAPTURE THE EVENT ON 5/18/2023.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19021101 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RÉVISION FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 18838317 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD 2 FEB 2024 WAS REVIEWED BY THE CLINICIAN. ON (B)(6) 2015 THE PATIENT HAD A RIGHT KNEE ARTHROPLASTY TO ADDRESS RIGHT NEE SEVERE VARUS OSTEOARTHRITIS WITH FLEXION CONTRACTURE. DEPUY COMPONENTS WERE PLACED AT THIS TIME. *ON (B)(6) 2015 THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA TO ADDRESS ARTHROFIBROSIS RIGHT KNEE. *ON (B)(6) 2022 THE PATIENT HAD A REVISION RIGHT KNEE TO ADDRESS A FAILED RIGHT KNEE WITH LOOSE TIBIAL COMPONENT DEBONDING AT CEMENT/IMPLANT INTERFACE, MEDICAL TIBIAL BONE LOSS, AND SEVERE VARUS POSITIONING. THE INDICATIONS FOR SURGERY INCLUDED SUBSIDENCE OF THE TIBIAL COMPONENT ALONG WITH PROGRESSIVE DEFORMITY AND WORSENING FUNCTION. DURING THE PROCEDURE, THE SURGEON OBSERVED EXTENSIVE AMOUNTS OF VERY INFLAMED SYNOVIUM. THE TIBIAL TRAY WAS FOUND TO BE GROSSLY LOOSE. THE FEMORAL COMPONENT WAS WELL POSITIONED AND FIXED BUT WAS REVISED AS THE KNEE WAS BEING SWITCHED TO COMPETITOR PRODUCTS. THE PATELLA WAS WELL FIXED AND POSITIONED, AND IT WAS LEFT IN SITU. COMPETITOR PRODUCTS, INCLUDING COMPETITOR CEMENT, WERE UTILIZED DURING THIS PROCEDURE. DOI: (B)(6) 2015 DOR: (B)(6) 2022 RIGHT KNEE.

  Patient problems: Adhesion(s); Synovitis

  MAUDE report 18753984 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATTUNE PRIMARY REVISED FOR TIBIAL LOOSENING AFTER 4 YEARS OF IMPLANTATION. TIBIAL TRAY LIFTED OUT OF PATIENT. BACKSIDE OF TRAY COMPLETELY CLEAN. SCORE MARKS ON UNDERSIDE OF POLY IMPLYING BACKSIDE WEAR. GREY COLORED MEMBRANE TISSUES REMOVED FROM PATIENT INDICATE POSSIBLE METALLOSIS.

  Patient problems: Foreign Body Reaction

  MAUDE report 18425671 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD TOTAL REVISION DUE TO PAIN, STIFFNESS, AND FEMORAL COMPONENT LOOSENING. THE DEBONDING WAS BETWEEN THE BONE AND CEMENT, NOT THE FEMORAL COMPONENT AND CEMENT. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 18084612 ↗