ATTUNE 1549-06-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295383086), received between Nov 26, 2018 and Apr 20, 2026 — classified as 35 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (7 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE WHEN WALKING AND REQUIRED REVISION SURGERY DUE TO LOOSENING OF IMPLANTS. THE REVISION PROCEDURE WAS PERFORMED TO ADDRESS PAIN AND IMPLANT LOOSENING AT AN UNKNOWN INTERFACE, AND ALL AFFECTED IMPLANTS WERE EXPLANTED AND DISCARDED. PATIENT HAD 3 PREVIOUS REVISIONS ON THIS KNEE.

  Patient problems: Pain

  MAUDE report 24927599 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN & INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24367469 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN & INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24366765 ↗
• InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. DOI: (B)(6) 2019. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 24365709 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT HOME AFTER SURGERY AND FELL, RESULTING IN A PERI-PROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23958291 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT HOME AFTER SURGERY AND FELL, RESULTING IN A PERI-PROSTHETIC FRACTURE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Limb Fracture

  MAUDE report 23958285 ↗
• InjuryNov 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL KNEE REVISION DONE BY THE DOCTOR AT THE HOSPITAL (B)(6) 2020. FEMUR BECAME LOOSE AND PATIENT WAS BROUGHT IN BY THE HOSPITAL FOR A FEMUR REVISION. FEMORAL COMPONENTS AND RP REVISION INSERT WERE REMOVED. THE RP REVISION TIBIA WAS NOT LOOSE AND STAYED IMPLANTED. NO COMPLICATIONS OR DELAYS IN SURGERY DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23633099 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION KNEE PLACED ON THE ABOVE LISTED DATE. THE PATIENT HAS HAD MILD PAIN SINCE THIS TIME. RECENT ASPIRATION WAS POSITIVE FOR INFECTION WHICH COULD HAVE BEEN PRESENT SINCE THE TIME OF REVISION. A ONE STAGE REVISION WAS PERFORMED AS THE ORGANISM IS SENSITIVE. ALL COMPONENTS WERE WELL FIXED AND WELL ALIGNED AND THE KNEE WAS WELL BALANCED. ALL COMPONENTS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. NEW COMPONENTS, ALONG WITH PLACEMENT OF RESORBABLE ANTIBIOTIC BEADS WERE PLACED IN A DUAL SET UP FASHION. NO DELAYS NOR PATIENT HARM WAS NOTED. SURGEON ROUTINELY UTILIZES DEPUY 2 WITH GENT FOR REVISION KNEE REPLACEMENTS. CEMENT IS HAND MIXED IN A BOWL. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22772048 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A RIGHT KNEE REVISION OCCURRED ON (B)(6) 2024 DUE TO A FRACTURED FEMUR POST INITIAL SURGERY. THE ORIGINAL IMPLANT SURGERY WAS AN UNKNOWN DATE IN 2020. THERE WAS NO SURGICAL DELAY AND NO ADDITIONAL PATIENT CONSEQUENCES.

  Patient problems: Limb Fracture

  MAUDE report 20303101 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INSTABILITY. FEMORAL COMPONENT AND POLY WERE REMOVED AND REPLACED WITH LPS COMPONENTS. THERE WAS NO LOSS OF CASE TIME. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19567702 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD A REVISION AND ALL WENT WELL. THE IMPLANT LOOKED GOOD, AND NO SPECIAL SIGNS WERE VISIBLE. THE IMPLANTS WENT OFF TO HOSPITAL (B)(6) FOR SONIFICATION AND ARE NOT AVAILABLE ANYMORE. THE PATIENT DID GET A CEMENT SPACER AS A TEMPORARY REPLACEMENT INCLUDING ANTIBIOTIC TREATMENT AND WILL GET A NEW IMPLANT SOON. AT THE MOMENT IT WILL BE AN IMPLANT FROM A DIFFERENT PROVIDER.

  Patient problems: Unspecified Infection

  MAUDE report 18414012 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A PERIPROSTHETIC FEMUR FRACTURE. FRACTURE JUST ABOVE THE CEMENTED STEM. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Limb Fracture

  MAUDE report 18364642 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR A PERIPROSTHETIC FEMUR FRACTURE. FRACTURE JUST ABOVE THE CEMENTED STEM. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT.

  Patient problems: Limb Fracture

  MAUDE report 18364494 ↗
• InjurySep 19, 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 A KNEE INFECTION. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17772971 ↗
• InjurySep 19, 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 A KNEE INFECTION. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17772741 ↗
• InjuryDec 5, 2022Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  3RD REVISION . ATTUNE REVISION FEMUR LOOSENING.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 15914601 ↗
• InjuryNov 28, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FEMORAL SLEEVE AND TIBIAL SLEEVE BEING LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15870806 ↗
• InjuryNov 28, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO FEMORAL SLEEVE AND TIBIAL SLEEVE BEING LOOSE AT THE BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15870246 ↗
• InjuryNov 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 15769619 ↗
• InjuryNov 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Insufficient Information

  MAUDE report 15769608 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MEDICAL RECORDS FROM (B)(6) 2022 NOTED THAT THE PATIENT HAD A LEFT TOTAL KNEE REVISION COMPLETED ON 05/04/2022. AFTER THE REVISION, THE PATIENT HAD ERYTHEMA OVER THE INCISION AND A STITCH ABSCESS WAS CUT OUT. PATIENT REPORTS HAVING PAIN DUE TO THE SUPERFICIAL INFECTION". NOTE: THE PATELLA WAS LEFT IN SITU DURING (B)(6)2022 REVISION.

  Patient problems: Abscess; Erythema; Pain; Unspecified Infection

  MAUDE report 15257776 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR INFECTION, PATIENT HAD BEEN REVISED FOR INFECTION IN THE PAST.

  Patient problems: Unspecified Infection

  MAUDE report 15191276 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID REVISION SURGERY ON (B)(6) 2019 AT CHA. THE KNEE IS NOW INFECTED SO THE SURGEON REMOVED ALL COMPONENTS AND PUT IN AN ANTIBIOTIC KNEE SPACER. DOI: (B)(6) 2019 - DOR: (B)(6) 2021 (RIGHT KNEE).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12496684 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS A LEFT BKA AND USES A WHEEL CHAIR FOR MOBILITY. PATIENT WAS USING HIS R LEG TO ¿PULL¿ HIS WHEELCHAIR ACROSS A GRASSY AREA AND FELT A ¿THUNK¿. HE DID NOT PRESENT FOR EXAM UNTIL 2 WEEKS LATER, AT WHICH TIME X-RAYS SHOWED THE KNEE DISLOCATED. SURGEON AND ASSISTANT WERE UNABLE TO REPRODUCE THE DISLOCATING MECHANISM WHILE THE PATIENT WAS PARALYZED FOR SURGERY. A FEMORAL REVISION WAS PERFORMED, IMPLANTING A HINGED CONSTRUCT. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT KNEE,

  Patient problems: Joint Laxity

  MAUDE report 12288478 ↗
• InjuryAug 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS A LEFT BKA AND USES A WHEEL CHAIR FOR MOBILITY. PATIENT WAS USING HIS R LEG TO ¿PULL¿ HIS WHEELCHAIR ACROSS A GRASSY AREA AND FELT A ¿THUNK¿. HE DID NOT PRESENT FOR EXAM UNTIL 2 WEEKS LATER, AT WHICH TIME X-RAYS SHOWED THE KNEE DISLOCATED. SURGEON AND ASSISTANT WERE UNABLE TO REPRODUCE THE DISLOCATING MECHANISM WHILE THE PATIENT WAS PARALYZED FOR SURGERY. A FEMORAL REVISION WAS PERFORMED, IMPLANTING A HINGED CONSTRUCT. DOI: (B)(6) 2021, DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12288469 ↗