ATTUNE 1506-11-004Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10603295416265), received between Jul 3, 2018 and Aug 17, 2026 — classified as 62 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (23 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 63 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  The patient was revised due to instability.Affected side: Right Knee

  Patient problems: Joint Laxity

  MAUDE report 50275281 ↗
• InjuryMar 17, 2026Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE OPERATIVE SIDE IS LEFT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24615413 ↗
• InjuryMar 4, 2026Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED : MEDICAL ADVISOR ON (B)(6) 2026. "ONE LADY WAS PRETTY BIG PERSON - SOLID, SHE WAS DOING OKAY AND HAD A FALL AND KEPT COMPLAINING OF KNEE PAIN FOR A LONG TIME, 15-19 MONTH SHOWED TOO MUCH ACTIVITY ON BONE SCAN, SHE WAS SUBSEQUENTLY REVISED. "JUST A BIT OF ADDITIONAL BONE SCAN ACTIVITY THAT PERSISTED. "ELECTRICAN WENT BACK TO WORK EARLY - AFTER 3M OR LESS THE YWERE BACK TO WORK IT¿S A PHYSICAL JOB IN THE COUNTRY". GOT THE BIOMECHANICS REPORTS - FIBROSIS INGROWTH. "ANOTHER RETIRED CARPENTER - DID WELL FOR 3 MONTHS, JUMPED INTO A POOL AND BOTTOMED OUT. AT THE TIME HE ALMOST VOMITED WITH PAIN. HAD ONGOING DISCOMFORT AND WAS REVISED. "ANOTHER GUY WHO HAD LOOSENING ON FEMUR, RETIRED TOUGH GUY, TOTAL KNEE, WENT ON DO A 1000KM WALK 2-3 MONTHS POST SURGERY. SUFFERED ASEPTIC LOOSENING OF FEMUR. "ANOTHER LADY LATE 60S, SHE KEPT COMPLAINING OF PAIN, WONDERED IF SHE GOT OSTEOPOROSIS. BONE SCAN RESULTS SHOWED ASEPTIC LOOSENING OF BASEPLATE. NOT ACTIVE LIFESTYLE"

  Patient problems: Inadequate Osseointegration

  MAUDE report 24505177 ↗
• InjuryMar 2, 2026Migration

  IT WAS REPORTED THAT THE TIBIAL BASEPLATE HAD SUBSIDED, AND NEEDED TO BE REVISED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24482782 ↗
• InjuryDec 31, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) AT (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.

  Patient problems: Pain

  MAUDE report 23934486 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (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 INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23934016 ↗
• InjuryDec 22, 2025Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO TIBIAL LOOSENING. LOOSENING INTERFACE WAS MARKED AS BONE TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23871320 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF STIFFNESS AND PAIN. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 23011707 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT KNEE REVISED DUE TO INSTABILITY. DOI: (B)(6) 2023, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22238165 ↗
• InjuryMar 24, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR AND TIBIA AT THE BONE TO IMPLANT INTERFACE. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21675999 ↗
• InjuryFeb 13, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO CEMENTED TIBIAL TRAY LOOSENING FOR POOR BONE QUALITY CAUSING SUBSIDENCE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21373673 ↗
• InjuryFeb 12, 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 21364256 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT FELL POST-OPERATIVELY. KNEE REVISION COMPLETED POST TRAUMA.

  Patient problems: Fall

  MAUDE report 21257066 ↗
• InjuryNov 18, 2024Migration; Migration

  IT WAS REPORTED, THAT PATIENT UNDERWENT REVISION SURGERY, DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE.

  Patient problems: Insufficient Information

  MAUDE report 20713603 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF KNEE PAIN. DOCTOR DECIDED TO DO A REVISION OF PRIMARY TKA. DOI: UNKNOWN. DOR: UNKNOWN. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19950744 ↗
• InjuryJun 28, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  ADDITIONAL INFORMATION STATES THAT THERE WAS NO DEFICIENCY WITH THE ATTUNE PS RP INSERT SZ5 5MM BECAUSE THEY CHANGED IT TO A NEW ONE AND THERE WAS NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19633307 ↗
• InjuryJun 7, 2024Osseointegration Problem; Migration; Osseointegration Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A PRIMARY TKA FOR RIGHT OA WITH THE ATTUNE. ON (B)(6) 2024, ANTERIOR SUBSIDENCE AND SIGNIFICANT LOOSENING OF THE TIBIAL TRAY WAS CONFIRMED DURING OUTPATIENT VISIT. A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2024. THERE ARE NO LOOSENING OR FAILURES EXCEPT IN THE TIBIAL TRAY. ONLY THE TIBIAL TRAY IS PLANNED TO BE REPLACED, BUT THE INSERT IS ALSO PLANNED TO BE REPLACED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19492897 ↗
• InjuryJun 6, 2024Osseointegration Problem; Osseointegration Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE WERE NO DELAYS IN SURGERY. THE DATE OF IMPLANTATION REMAINED UNCLEAR ALTHOUGH IT WAS MENTIONED IT WAS AROUND 2022.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19478834 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT TOTAL KNEE WAS REVISED DUE TO COMPLAINING OF PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 19381170 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023, DOE 06 MAY 2024. AFFECTED SIDE: LEFT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19340914 ↗
• InjuryApr 9, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIA COMPONENT AT THE BONE TO IMPLANT INTERFACE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19069381 ↗
• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: DPO_14022 CLINICAL ADVERSE EVENT RECEIVED FOR QUADRICEPS TENDINOPATHY. 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) 2022 (RIGHT KNEE) TREATMENT: INJECTION OF LOCAL ANESTHETIC AND CORTISONE.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 19061914 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 18886709 ↗
• InjuryFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 18658725 ↗
• InjuryDec 28, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIAL COMPONENT AT UNKNOWN INTERFACE. IMPLANT IS A PRESSFIT ROTATING PLATFORM TIBIA. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18410704 ↗