ATTUNE 1513-06-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295475149), received between Jan 15, 2019 and Oct 28, 2025 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR CHRONIC RIGHT MEDIAL POSTERIOR KNEE PAIN DEVICE RELATED: REMOTE POSSIBILITY. PROCEDURE RELATED: POSSIBLY DATE OF EVENT: 7 JAN 2025. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INJECTED MEDICATION, PHYSICAL THERAPY.

  Patient problems: Pain

  MAUDE report 23404921 ↗
• MalfunctionApr 21, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING THE SURGERY, THE ADAPTER IMPLANT WAS OPENED TO BE ASSEMBLED AND AT THE TIME OF THE USE, IT HAD FAILURES. THE THREAD DID NOT ROTATE IN EITHER WAY AND APPARENTLY IT ARRIVED DEFECTIVE, WHICH MADE IT IMPOSSIBLE TO USE IT IN THE DEFINITIVE PROSTHESIS. SURGEON PROCEEDED BY CHANGING IT FOR ANOTHER IMPLANT OF THE SAME REFERENCE AND LOT. THERE WAS APPROXIMATELY (20) TWENTY MINUTES OF SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED, WITH NO PATIENT IMPACT. PATIENT OUTCOME IS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878003 ↗
• 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 ENTRAPEMENT 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: 151306000, LOT NUMBER ID: 8780621, COMPONENT TYPE: TIBIAL STEM OFFSET ADAPTOR, DEVICE IDENTIFIER: (B)(4).

  Patient problems: Nerve Damage

  MAUDE report 20590623 ↗
• InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6), STUDY NO: (B)(6). CLINICAL ADVERSE EVENTS RECEIVED FOR INSTABILITY. DATE OF EVENT: 24 OCT 2019, DATE OF IMPLANT: (B)(6) 2019, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: HOSPITALIZATION AND CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Laxity

  MAUDE report 20536484 ↗
• 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 17772911 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PATIENT COMPLAINTS OF PAIN. SURGEON REVISED STEM TO A SHORTER STEM. DOI: (B)(6) 2022, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16777303 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS IN JOINT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2017, DATE OF EVENT: (B)(6) 2018 (RIGHT KNEE). TREATMENT: INJECTED MEDICATION, ORAL MEDICATION, AND PHYSICAL THERAPY.

  Patient problems: Muscular Rigidity

  MAUDE report 16452020 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POST-OPERATIVE ANEMIA. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2021, DATE OF EVENT: (B)(6) 2021, (LEFT KNEE). TREATMENT: BLOOD TRANSFUSION.

  Patient problems: Anemia

  MAUDE report 12234638 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTING PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS PROBABLY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: INJECTED AND ORAL MEDICATIONS (UNSPECIFIED), PHYSICAL THERAPY.

  Patient problems: Pain

  MAUDE report 11933374 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS NOW RECEIVED A NEURECTOMY AS TREATMENT.

  Patient problems: No Code Available

  MAUDE report 10665158 ↗
• InjuryApr 23, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  WAS JUST REVIEWING MEDIDATA REPORTS WITH ROB TO SHOW HIM HOW TO PULL AND REVIEW THOSE AND PULLED THE MDC REPORT AS AN EXAMPLE FOR REVISION. WE NOTICED THAT THERE ARE SOME ¿DISSATISFIED¿ SCORES AT THE 6 WEEK MARK.

  Patient problems: No Code Available; Pain

  MAUDE report 9993817 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR REVISION OF PTG G FOR INSTABILITY AND TIBIAL OVERFLOW AND MOBILIZATION UNDER GENERAL ANESTHESIA. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS DEFINITELY NOT RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE).

  Patient problems: No Code Available

  MAUDE report 9504144 ↗
• MalfunctionJan 15, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE BOLT OF THE OFFSET STEM ADAPTER WAS TOO TIGHT AND COULD NOT BE TWISTED WHEN THE SURGEON ATTEMPTED TO USE IT DURING THE TKA SURGERY.

  Patient problems: Not Applicable

  MAUDE report 8248057 ↗