ATTUNE AFFIXIUM 1506-21-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295507406), received between Aug 9, 2023 and Apr 23, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Migration” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Osseointegration Problem

  IT WAS REPORTED THAT PATIENT HAS COMPLAINED OF CONSTANT TIBIAL PAIN. ASEPTIC LOOSENING OF THE TIBIA. DOI: (B)(6) 2025. DOR: UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 24966071 ↗
• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT KNEE WAS INFECTED. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24099265 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS REFERS TO A REVISION THAT TOOK PLACE IN AN INVESTIGATOR INITIATED CLINICAL STUDY (ATTUNE CEMENTLESS RSA STUDY). ONE PATIENT IN THIS STUDY RECENTLY UNDERWENT A FULL REVISION AT 11 MONTHS POST-OP. THE PATIENT HAD SWELLING AND PAIN UPON PRESENTATION TO THE CLINIC IN (B)(6) (UNSCHEDULED VISIT). AN INTERIM CT-RSA WAS PERFORMED WHICH SHOWED NO DISCERNIBLE MIGRATION OF THEIR TIBIAL TRAY, NO OBVIOUS MIGRATION THAT WOULD SUGGEST LOOSENING. THE PATIENT WAS REVISED ON (B)(6) 2025 FOR INFECTION (STAGE 1 OF 2-STAGE PROCEDURE). DR. PERFORMED THE REVISION AND NOTED THE 4 PERIPHERAL PEGS OF THE TRAY WERE SOLIDLY INGROWN.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 23688553 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 21405051 ↗
• InjuryDec 27, 2024Adverse 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 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 INFECTION AND PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21028197 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR AN EXPLANT AND REPLANT DUE TO INFECTION. THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTS THEMSELVES. DOI: UNKNOWN, DOR: (B)(6) 2024 , AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20534201 ↗
• InjuryAug 5, 2024Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  ADDITIONAL INFORMATION RECEIVED: A REVISION SURGERY IS SCHEDULED FOR (B)(6) 2024. IN THE REVISION SURGERY, THE IMPLANT ON THE TIBIAL SIDE IS REMOVED AND REPLACED WITH A TRAY WITH A STEM. IF LOOSENING OF THE FEMORAL IMPLANT IS ALSO OBSERVED, THE FEMORAL IMPLANT IS REMOVED AND IS REPLACED WITH A PS OR CRS. INTRAOPERATIVE CULTURE WILL BE PERFORMED TO CONFIRM WHETHER INFECTION HAS OCCURRED OR NOT.

  Patient problems: Pain

  MAUDE report 19906417 ↗
• InjuryMay 7, 2024Migration; Migration

  IT WAS REPORTED THAT ON MAR. 27, 2024, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR OA FOR THE RIGHT KNEE JOINT WITH THE IMPLANT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2024, IT WAS OBSERVED THAT ONLY THE PRODUCT IN QUESTION HAD A SLIGHT SINKING IN THE ANTERIOR INTERIOR. CONSIDERING THAT THE PATIENT'S CURRENT COMPLAINT IS NOT EXCESSIVE PAIN, THE SURGEON DECIDED TO MAINTAIN THE PATIENT'S CURRENT CONDITION BY UNLOADING. IF SINKING OR POOR ALIGNMENT DEVELOPS IN THE FUTURE, THE SURGEON WILL CONSIDER REVISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19258957 ↗
• InjuryMar 7, 2024Migration; Migration

  SUBSIDED TIBIAL TRAY WAS REVISED. PRIMARY SURGERY WAS ON (B)(6) 2023. POST OP X-RAY LOOKED GOOD. X-RAY WAS TAKEN WHEN SHE PRESENTED TO THE SITE ON (B)(6) 2023 WITH PAIN. X-RAY SHOWED SUBTLE SUBSIDENCE LATERALLY. AT HER 6 WEEK VISIT ON (B)(6) 2023 SHE SAID SHE COMPLAINED OF PAIN AND A CROOKED LEG. X-RAYS AT THIS TIME SHOWED GROSS SUBSIDENCE LATERALLY AND LIFT OFF MEDIALLY. SHE WAS REVISED TO A REVISION TIBIA ON (B)(6) 2023.

  Patient problems: Pain

  MAUDE report 18855924 ↗
• InjurySep 22, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PROXIMAL TIBIAL PAIN. THE CONCERN EXISTED FOR A LOOSE TIBIA AT THE BONE TO IMPLANT INTERFACE. UPON EXAMINATION, THE TIBIAL TRAY WAS WELL FIXED. IT APPEARED THAT THE CENTER POST HAD GROWN IN. HOWEVER, THE UNDERSIDE OF TIBIA PEGS WERE NOT INGROWN. THE SURGEON ELECTED TO REVISE THE TIBIA. DOI: (B)(6) 2022 .DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17797592 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL ADVERSE EVENT RECEIVED FOR PINS AND NEEDLES L KNEE AND LIMITED ROM. 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) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT KNEE) (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

  Patient problems: Loss of Range of Motion; Paresthesia

  MAUDE report 17488396 ↗