ATTUNE 1547-07-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295382829), received between Mar 19, 2020 and Jul 27, 2026 — classified as 14 injuries.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient contracted MRSA, all implants removed and replaced with antibiotic spacer.DOI: Unknown.DOR: Unknown.Affected Side: Left Knee.

  Patient problems: Unspecified Infection

  MAUDE report 50039507 ↗
• 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 22730714 ↗
• 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 22730697 ↗
• InjuryJul 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22621488 ↗
• 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: 154707002, LOT NUMBER ID: HW2120, COMPONENT TYPE: FEMORAL LATERAL DISTAL AUGMENT, DEVICE IDENTIFIER: 10603295382829.

  Patient problems: Nerve Damage

  MAUDE report 20590546 ↗
• InjuryNov 1, 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 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: NO INFORMATION PROVIDED, DATE OF REVISION: ON (B)(6) 2019, DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: INFORMATION NOT PROVIDED.

  Patient problems: Nerve Damage

  MAUDE report 20590515 ↗
• 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 19058645 ↗
• 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 19058631 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. DATE OF IMPLANTATION (B)(6) 2021. B. LOT NUMBER: ATTUNE CRS FEMORAL RT SZ 7 CEM (150440207) - LOT # J8602J. ATUNE PRESSFIT STR STEM24X60MM (151324060) - LOT # J06R66. REFER TO ADDITIONAL EVENT INFORMATION A-6001132 WHICH HAS THE USAGE FROM THE PRIMARY SURGERY. C. PLEASE CONFIRM IF THE CEMENT WAS MANUFACTURED BY DEPUY? IF YES, PLEASE PROVIDE THE QUANTITY, PART AND LOT NUMBERS OF THE CEMENT. UNKNOWN. D. WAS SURGERY TIME EXTENDED? IF YES, WHAT WAS THE DURATION OF THE DELAY? AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

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

  MAUDE report 12261829 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE (B)(6) 2021 THE PATIENT HAD A ATTUNE REVISION REMOVED DUE TO INFECTION. I HAVEN'T BEEN ABLE TO OBTAIN THE PRODUCT LOT NUMBERS THAT WERE IN THE PATIENT. I WILL NEED TO CONTACT THE SURGEON OF THESE AS THE NURSING STAFF AT THE HOSPITAL WERE UNSURE. THE SURGEON PUT AN PALACOS ANTIBIOTIC CEMENT SPACER INTO THE PATIENT. THE IMPLANTS REMOVED: FEMORAL COMPONENT WITH FULLY PORUS SLEEVE AND PRESSFIT STEM, TIBIAL COMPONENT WITH FULLY PORUS SLEEVE, PRESSFIT STEM AND TIBIAL CRS INSERT.

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

  MAUDE report 11332897 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE (B)(6) 2021 THE PATIENT HAD A ATTUNE REVISION REMOVED DUE TO INFECTION. I HAVEN'T BEEN ABLE TO OBTAIN THE PRODUCT LOT NUMBERS THAT WERE IN THE PATIENT. I WILL NEED TO CONTACT THE SURGEON OF THESE AS THE NURSING STAFF AT THE HOSPITAL WERE UNSURE. THE SURGEON PUT AN PALACOS ANTIBIOTIC CEMENT SPACER INTO THE PATIENT. THE IMPLANTS REMOVED: FEMORAL COMPONENT WITH FULLY PORUS SLEEVE AND PRESSFIT STEM, TIBIAL COMPONENT WITH FULLY PORUS SLEEVE, PRESSFIT STEM AND TIBIAL CRS INSERT.

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

  MAUDE report 11332894 ↗
• 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 10665114 ↗
• 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 10664949 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A REVISION TOTAL KNEE DONE ELSEWHERE. CAME IN WITH INFECTION. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS INSERTED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9853261 ↗