ATTUNE 1504-01-226Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295041573), received between Oct 28, 2020 and Jun 25, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD REVISION TO ADDRESS POTENTIAL LOOSENING OF FEMORAL IMPLANT. IMPLANT WAS REMOVED, UNSURE IF LOOSE AS FEMUR WAS ADHERED TO LUGS AND OTHER POINTS. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25627105 ↗
• InjuryJun 23, 2026Use of Device Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAD REVISION DONE TO CORRECT PATELLA BAJA AND POTENTIAL CONCERN FOR LOOSENING OF PRESSFIT FEMUR. FEMUR WAS WELL FIXED AT THE POSTS. NOT SURE IF IT WAS TRULY LOOSE. NO OTHER ISSUES OR CONCERNS WERE GIVEN. DOI- (B)(6) 2024. DOR- (B)(6) 2026. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 25596891 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIA WITH AUGMENTS, POLY AND FEMUR WERE ALL REMOVED DUE TO INSTABILITY. ALL PIECES WERE REMOVED FROM THE PT. AND THE FIELD IMMEDIATELY IN THEIR ENTIRETY AND THERE WAS NO HARM DONE TO THE PATIENT. I HAVE NO FURTHER INFORMATION. AFFECTED SIDE: RIGHT.

  Patient problems: Joint Laxity

  MAUDE report 24903791 ↗
• InjuryAug 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE SURGEON REVISED A TKR. REASON FOR REVISION WAS PAIN AND LOOSENING. SURGEON REMOVED FEMUR, TIBIA AND POLY INSERT IMPLANTS WHICH WERE WELL FIXED AND IN GROWN. CEMENTLESS FEMUR APPEARED TO BE IMPLANTED IN FLEXED POSITION WHICH LEFT A GAP BETWEEN THE ANTERIOR DISTAL FEMORAL BONE AND THE IMPLANT. POSTERIOR FEMUR HAD VERY GOOD BONE IN GROWTH AND WAS DIFFICULT TO REMOVE. ATTUNE REVISION IMPLANTED. PATELLA WAS LEFT IN-SITU. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT.

  Patient problems: Pain

  MAUDE report 22877037 ↗
• InjuryMar 25, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT WANTED TO COMPLAIN THAT THE IMPLANT WAS NOT WORKING AT ALL.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Fall; Fatigue; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 21686392 ↗
• 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 20775442 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A BEARING SPIN . THE DECISION TO REMOVE ALL IMPLANTS AND REVISE TO ATTUNE REVISION AS THE KNEE HAD BECOME UNSTABLE IN FLEXION. BETTER RESULT AT END OF CASE.

  Patient problems: Joint Laxity

  MAUDE report 16713230 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO A PAINFUL POROUS ATTUNE KNEE THAT WAS REVISED TO ATTUNE REVISION APPROXIMATELY 4 YEARS OUT AND WAS LIKELY FIBROUS INGROWTH. THERE WAS NO SURGICAL DELAY. DOI: 4 YEARS AGO, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15470470 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTED KNEE. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13215170 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12505676 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, PATIENT RECEIVED A RIGHT ATTUNE TOTAL KNEE TO TREAT OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND DEPUY CEMENT WAS UTILIZED. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2019, PATIENT RECEIVED A RIGHT KNEE REVISION TO ADDRESS PAIN, DECREASE IN ACTIVE EXTENSION, DECREASE IN ACTIVE FLEXION, AND TIBIAL TRAY LOOSENING AT AN UNKNOWN INTERFACE. THE SURGEON DID NOT SPECIFY WHICH INTERFACE THE TIBIAL TRAY WAS LOOSE. ALL COMPONENTS WERE REVISED. THE PATIENT WAS REVISED WITH DEPUY PRODUCTS AND TWO DEPUY CEMENT PRODUCTS. THERE WERE NO INDICATED INTRAOPERATIVE COMPLICATIONS. DOI: (B)(6) 2017. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 11591144 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND LOOSENING OF THE TIBIAL IMPLANT AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10750879 ↗