ATTUNE 1547-05-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295382768), received between May 3, 2019 and Dec 23, 2025 — classified as 10 injuries.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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)(6). 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: ON (B)(6) 2020, DATE OF REVISION: NO INFORMATION PROVIDED, DEVICE LOCATION: LEFT, TREATMENT/IMPACT: OTHER: TRUE, IF OTHER ¿ SPECIFY: PLANNED TO HAVE REVISION SURGERY ON (B)(6) 2026.

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

  MAUDE report 23880547 ↗
• 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 23880537 ↗
• InjuryNov 14, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED: TREATMENT/IMPACT: DIAGNOSTIC INTERVENTION: NO => YES.

  Patient problems: Pain

  MAUDE report 23554142 ↗
• 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.

  Patient problems: Pain

  MAUDE report 23554063 ↗
• InjuryMar 7, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  SUBJECT ID: (B)(6). STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: REVISION.

  Patient problems: Insufficient Information

  MAUDE report 21548046 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED AN ATTUNE REVISION OPERATION TO REMEDY AN INFECTED PRIMARY CONSTRUCT (ZIMMER). THE ATTUNE REVISION CONSTRUCT HAS CAUSED THE PATIENT ISSUES SINCE SOON AFTER THE REVISION OPERATION. TODAY THE ATTUNE REVISION IMPLANTS WERE REMOVED DUE TO CONTINUED INFECTION ISSUES.

  Patient problems: Unspecified Infection

  MAUDE report 18713115 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION OF RIGHT (STUDY) KNEE. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: SURGICAL IRRIGATION & DEBRIDEMENT ORAL MEDICATION: YES (UNSPECIFIED).

  Patient problems: Unspecified Infection

  MAUDE report 14280114 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019, DATE OF EVENT (ONSET): (B)(6) 2021, (RIGHT KNEE). TREATMENT: SURGICAL IRRIGATION AND DEBRIDEMENT

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

  MAUDE report 12377961 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY SECONDARY TO ASEPTIC LOOSING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2019 DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12275571 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF RECURRING INFECTION. THE DOCTORS BELIEVED THE INFECTION HAD BEEN ERADICATED AND WENT AHEAD WITH THE REIMPLANTATION. AFTER MULTIPLE WASHOUTS AND WOUND VAC CHANGES, SURGEON HAD TO REMOVE IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8578811 ↗