ATTUNE 1504-40-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295042303), received between Apr 23, 2019 and Mar 31, 2026 — classified as 38 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIA AND FEMUR LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 24747429 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT IMPLANT REMOVAL DUE TO INFECTION. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22730696 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL POST KNEE REPLACEMENT AND HAD A PERIPROSTHETIC FRACTURE. IN A SEPARATE SURGERY, THEY ADDED A DISTAL FEMUR CONDYLAR PLATE. PATIENT FELL AGAIN, AND BROKE PROXIMAL TO THE PLATE. THE PLAN WAS TO REMOVE THE FEMUR AND USE A DISTAL FEMUR REPLACEMENT. HOWEVER THE PATIENT HAS AN ACTIVE KNEE INFECTION, AND PUSS WAS IN THE SURGERY SITE. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Fall; Unspecified Infection

  MAUDE report 21962849 ↗
• InjuryMar 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT DISLOCATED THEIR ANTIBIOTIC SPACER AND GETS CHRONIC INFECTIONS. DOCTORS REMOVED ALL IMPLANTS AND CEMENTED IN AN XFIX. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 21712430 ↗
• InjuryMar 12, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION IN HER ANTIBIOTIC SPACER AND GETS CHRONIC INFECTIONS. STAFF REMOVED ALL IMPLANTS AND CEMENTED IN AN XFIX. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 21584645 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES: CLINICAL ADVERSE EVENT RECEIVED FOR ENTRAPMENT RAMUS INFRAPATELLARIS. DEVICE AND PROCEDURE (RELATEDNESS): REMOTE POSSIBILITY RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF EVENT: UNK DECEMBER 2020, DATE OF IMPLANT: ON (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NEURECTOMIE. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 150440207, LOT NUMBER ID: HF5013, COMPONENT TYPE: FEMORAL COMPONENT, DEVICE IDENTIFIER: (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 20590637 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. IT WAS REPORTED FROM CLINICAL STUDY AN ADVERSE EVENT RECEIVED FOR KNEE REVISION ON (B)(6) 2024 DUE TO JOINT INSTABILITY. DATE OF IMPLANT WAS (B)(6) 2022.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20428416 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS A KNOWN STAPH EPI INFECTION. ALL COMPONENTS WERE REMOVED. THERE WAS NO SURGICAL DELAYS. THERE WAS NO PATIENT CONSEQUENCES. NO PARTS WERE BROKEN. LOT NUMBERS WERE NOT VISIBLE. DOI: UNKNOWN. DOR:(B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19764566 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT: ON (B)(6) 2022, THE PATIENT WAS REVISED DUE TO PAIN, AND DEBONDING AT THE COMPETITOR TIBIAL TRAY AND DEPUY CEMENT INTERFACE. (REPORTED ON (B)(4)). AT REVISION, DEPUY COMPONENTS WERE IMPLANTED AT THAT TIME. DOI: (B)(6) 2021; DOR: (B)(6) 2022; (B)(4); AFFECTED SIDE: RIGHT KNEE. (B)(4). IT WAS REPORTED THAT THE PATIENT CONTINUES TO HAVE PAIN/SWELLING AND IS LOOKING AT ANOTHER REVISION.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19323165 ↗
• InjuryApr 8, 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. THERE WAS NO DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 19058666 ↗
• InjuryJan 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL COMPONENT AT UNKNOWN INTERFACE FROM INFECTION. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2019 DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE

  Patient problems: Unspecified Infection

  MAUDE report 18581570 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF EVENT: 16 MAY 2021. (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, DIAGNOSTIC INVENTION.

  Patient problems: Pain

  MAUDE report 18211842 ↗
• InjurySep 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF TIBIA AND FEMUR COMPONENT ON AN UNKNOWN INTERFACE. THE EVENT DID NOT HAPPEN IN SURGERY. DOI- UNKNOWN, DOR- (B)(6) 2023, AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17823860 ↗
• InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR HETEROTROPHIC OSSIFICATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF EVENT: (B)(6) 2023. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT WAS REVISED.

  Patient problems: Extraskeletal ossification

  MAUDE report 17571401 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 16742975 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION AND THEY PUT IN A PROSTALAC SPACER. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16403116 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SEPTIC LOOSENING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. SURGEON EXPLANTED FEMUR AND REVISED WITH TEMPORARY SPACER. DOI: (B)(6) 2021. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16184481 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018; DATE OF EVENT: (B)(6) 2022; (LEFT KNEE). TREATMENT: INJECTED MEDICATION (CORTISONE).

  Patient problems: Pain

  MAUDE report 15966226 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON REVISED KNEE DUE TO PATIENT DISCOMFORT, HE ALSO FELT THE KNEE WAS UNSTABLE. TIBIA SEEMED TO COME OUT EASIER THAN MOST, NOT SURE IF IT WAS LOOSE OR UNDERSIZED. NO OTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 15475703 ↗
• InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE ARTHROFIBROSIS AND LIMITED RANGE OF MOTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF EVENT: (B)(6) 2021. (RIGHT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 15162884 ↗
• InjuryJun 24, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION OF TOTAL KNEE TO ADDRESS LOOSE FEMUR EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): 03/01/2022 (RIGHT KNEE). TREATMENT: REVISION OF FEMORAL CONSTRUCT.

  Patient problems: Insufficient Information

  MAUDE report 14799614 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY: DSJ-2016-02 NEW CLINICAL ADVERSE EVENT RECEIVED FOR RIGHT KNEE LIMITED RANGE OF MOTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2021. DATE OF EVENT: UNK MAY 2021. AFFECTED AREA: (RIGHT KNEE). TREATMENT: AWAITING MANIPULATION UNDER ANESTHESIA

  Patient problems: Loss of Range of Motion

  MAUDE report 14655649 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND LOOSENING. IT IS UNKNOWN WHICH PRODUCTS AND INTERFACES WERE LOOSE.

  Patient problems: Pain

  MAUDE report 13791976 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: 12-006. STUDY: DSJ-2016-03. CLINICAL ADVERSE EVENT RECEIVED FOR SLID OUT OF A WHEELCHAIR AND SUFFERED A PERIPROSTHETIC FEMUR FRACTURE. EVENT IS SERIOUS AND IS CONSIDERED MODERATE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND THERE IS A REMOTE POSSIBILITY IT IS RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2021. DATE OF EVENT (ONSET): (B)(6) 2021. (RIGHT KNEE). TREATMENT: OPEN REDUCTION INTERNAL FIXATION OF FEMUR.

  Patient problems: Bone Fracture(s)

  MAUDE report 13117320 ↗
• MalfunctionSep 28, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE FEMURAL IMPLANT DID NOT FIT WHEN WE WENT TO CEMENT THE KNEE. NO DELAY OCCURRED BECAUSE WE HAD BACKUP IMPLANTS IN TERRITORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541441 ↗