ATTUNE 1549-05-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295383055), received between May 3, 2019 and Jul 7, 2026 — classified as 40 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSE FEMUR AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI-UNKNOWN. DOR (B)(6) 2026. AFFECTED SIDE-UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25732477 ↗
• InjuryJul 7, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSE FEMUR AT THE UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI-UNKNOWN. DOR-(B)(6) 2026. AFFECTED SIDE-UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25732355 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURE ABOVE THE REVISION COMPONENTS. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 24618343 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO FRACTURE ABOVE THE REVISION COMPONENTS. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 24618341 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO THE REMOVAL OF IMPLANTS FOR INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24327415 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSSIBLE INFECTION OF REVISION RTKA THAT WAS IMPLANTED (B)(6) 2024. REMOVED ALL IMPLANTS AND WASHED OUT AND PERFORMED A 1 1/2. STAGE REVISION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24054499 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POSSIBLE INFECTION OF REVISION RTKA THAT WAS IMPLANTED (B)(6) 2024. REMOVED ALL IMPLANTS AND WASHED OUT AND PERFORMED A 1 1/2. STAGE REVISION. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24054391 ↗
• InjuryDec 23, 2025Loss of or Failure to Bond; No Apparent Adverse Event; Loss of or Failure to Bond; No Apparent Adverse Event

  SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL AND FEMORAL COMPONENT LOOSENING ON INDEX KNEE DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: UN JAN 2025. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: LEFT TREATMENT/IMPACT: OTHER: TRUE. IF OTHER ¿ SPECIFY: PLANNED TO HAVE REVISION SURGERY IN (B)(6) OF 2026.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880548 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A REVISION KNEE IN 2023; THERE WAS A PROXIMAL STRUT ALLOGRAFT PUT ON AT SOME POINT AFTER THE REVISION. THE PATIENT HAD PROXIMAL FEMOR PAIN, THE BONE SCAN SHOWED LOOSENING. A REVISION WAS PLANNED. KNOCKED THE SIZE 5 FEMOR OFF, THERE WAS NO LOOSENING OF OUR FEMORAL SLEEVES OR TIBIAL IMPLANTS. THE ALLOGRAFT WAS LOOSE, AND CABLES WERE LOOSE. THE SURGEON DECIDED TO RETRO FIT A NEW CRS REVISION SIZE 5 LEFT FEMORAL COMPONENT BACK INTO THE WELL INGROWN SLEEVE. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23879734 ↗
• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL EVENT INFORMATION REVIEWED AND RECEIVED ON 04-NOV-2025 AND 03-NOV-2025: UPDATES RECEIVED: DEVICE RELATED: POSSIBLY. PROCEDURE RELATED: DEFINITELY. CLINICAL UPDATE RECEIVED ON 26 NOV 2025: UPDATES RECEIVED: DIAGNOSIS: LATERAL KNEE PAIN ON LEFT KNEE FOUND TO HAVE TIBIAL AND FEMORAL COMPONENT LOOSENING: LATERAL KNEE PAIN. ADDITIONAL EVENT INFORMATION REVIEWED AND RECEIVED: CLINICAL ADVERSE EVENT RECEIVED FOR TIBIAL AND FEMORAL COMPONENT LOOSENING ON INDEX KNEE. TREATMENT/IMPACT: OTHER (PLANNED TO HAVE REVISION SURGERY IN (B)(6) 2026).

  Patient problems: Pain

  MAUDE report 23554245 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON REMOVED IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22968729 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN INFECTION. SURGEON REMOVED IMPLANTS AND PLACED AN ANTIBIOTIC SPACER. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22968151 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A CEMENT SPACER DUE TO INFECTION - ALL REVISION COMPONENTS WERE REMOVED AND CEMENT SPACER PLACED WHILE PATIENT WAS ON ANTIBIOTICS IN THE HOPES SHE WOULD CLEAR THE INFECTION. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22828091 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OPERATIVE X-RAYS SHOWED A FEMUR FRACTURE. SURGEON DECIDED TO REMOVE IMPLANTS AND REDUCE FRACTURE/REPOSITION KNEE REVISION. NO COMPLAINTS ABOUT INSTRUMENTATION OR IMPLANTS AND THERE WAS NO DELAY TO SURGERY TIME. THE FEMORAL BONE FRACTURED, THE IMPLANT WAS INTACT. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 22034896 ↗
• InjuryJan 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. LOOSENING INTERFACE WAS MENTIONED AS NOT APPLICABLE. THE CEMENT MANUFACTURER WAS DEPUY. NO SURGICAL DELAY. DOI: (B)(6), 2018 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21233068 ↗
• InjuryJan 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. LOOSENING INTERFACE WAS MENTIONED AS NOT APPLICABLE. THE CEMENT MANUFACTURER WAS DEPUY. NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21232949 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WOUND HEALING DELAY. DEVICE AND PROCEDURE (RELATEDNESS): DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: DEFINITELY. DATE OF EVENT: 22 NOV 2018. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: IRRIGATION & DEBRIDEMENT, INJECTED MEDICATION.

  Patient problems: Impaired Healing

  MAUDE report 20461642 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATED EVENT DESCRIPTION: DATE OF REVISION: (B)(6) 2025. TREATMENT/IMPACT: REVISION OF STUDY JOINT, HOSPITALIZATION AND ATTUNE TIBIAL INSERT.

  Patient problems: Pain

  MAUDE report 19701923 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR WORSENING OF RIGHT SHIN PAIN LEADING TO POLY EXCHANGE AND PATELLAR RESURFACING. TREATMENT/IMPACT: HOSPITALIZATION, INJECTED MEDICATION, REVISION OF STUDY JOINT.

  Patient problems: Pain

  MAUDE report 19345980 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND SOFT TISSUE. EVERYTHING WAS TAKEN OUT AND SROM HINGE PUT BACK IN. UNKNOWN IF DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18172240 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND SOFT TISSUE. EVERYTHING WAS TAKEN OUT AND SROM HINGE PUT BACK IN. IT WAS UNKNOWN, IF DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- RIGHT KNEE.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 18172231 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A DISTAL FEMORAL REPLACEMENT DUE TO PRIOR INFECTION AND SOFT TISSUES STRETCHING EXTENSIVELY RESULTING IN THE DISLOCATION OF THE HINGED COMPONENT WITH THE LARGEST AVAILABLE POLY. THE DISTAL FEMORAL COMPONENT WITH A POROUS STEM WAS LOOSE AND REMOVED EASILY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 17058133 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  PATIENT UNDERWENT REVISION FOR INSTABILITY. PATIENT'S PRIMARY WAS WITH COMPETITOR PRODUCTS ON A UNKNOWN DATE. PATIENT HAD FIRST REVISION (REASON UNKNOWN) ON (B)(6) 22, WHERE OUR PRODUCTS WERE IMPLANTED. PATIENT HAD 2ND REVISION ON THE (B)(6) 22, FOR INSTABILITY, (B)(4). THEN A 3RD REVISION FOR INSTABILTY, THIS PC, ON THE (B)(6) 23.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17037496 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT, MALE, OPERATED ON THE LEFT SIDE FOR A KNEE REVISION, FOR A POSTOPERATIVE INFECTION.(SAPHEPIDERMIDIS). DATE OF THE FIRST INTERVENTION THE (B)(6) 2023. DATE OF REVISION (B)(6) 2023. THE REMOVED IMPLANTS WERE DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 16655238 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGERY DELAY? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO DELAY WAS REPORTED. B. HOW IS THE PATIENT NOW? THE PATIENT IS DOING WELL ACCORDING TO THE SURGEON. C. WERE THERE ANY PATIENT CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE DISLOCATION? JOINT/LIGAMENT LAXITY, PROGRESSION OF THE DISEASE, ETC. UNCLEAR. THE SURGEON STATED THAT HER COLLATERALS HAD BECOME LAX OVER TIME. CAUSE UNKNOWN. D. WAS THERE ANY SUGGESTION THAT THE ATTUNE REVISION PRODUCTS MAY HAVE BEEN OVERSIZED AT PRIMARY? NO. E. WHAT CAUSED THE FRACTURE? WAS IT A RESULT OF THE DISLOCATION? OR DID THE PATIENT HAVE A FALL? THE SURGEON BELIEVES THERE MAY HAVE BEEN A SMALL NONDISPLACED FRACTURE DURING FEMORAL METAPHYSEAL SLEEVE REMOVAL WHICH THEN EXPANDED DURING THE INSERTION OF THE SROM METAPHYSEAL SLEEVE CONSTRUCT. F. YOU MENTIONED IN THE EVENT DESCRIPTION THAT THE PATIENT HAD ATTUNE REVISION COMPONENTS IN SITU. HAS THE PATIENT UNDERGONE A PRIOR REVISION OF DEPUY PRODUCTS? IF YES, WAS IT REPORTED? (PROVIDE PC# IF POSSIBLE). OR WAS THE PATIENT'S PRIMARY CONSTRUCT NON-DEPUY? NON-DEPUY PRODUCT AT INDEX SURGERY.

  Patient problems: Bone Fracture(s); Joint Laxity

  MAUDE report 16407283 ↗