ATTUNE 1547-06-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295382799), received between Mar 19, 2020 and Jan 28, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 29 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL AND TIBIAL COMPONENTS).

  Patient problems: Unspecified Infection

  MAUDE report 24200724 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 29 DEC 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: 29 DEC 2025. DEVICE LOCATION: LEFT. TREATMENT/IMPACT: DEPUY SYNTHES COMPONENTS REMOVED (FEMORAL AND TIBIAL COMPONENTS).

  Patient problems: Unspecified Infection

  MAUDE report 24200719 ↗
• InjuryNov 24, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL KNEE REVISION DONE BY THE DOCTOR AT THE HOSPITAL (B)(6) 2020. FEMUR BECAME LOOSE AND PATIENT WAS BROUGHT IN BY THE HOSPITAL FOR A FEMUR REVISION. FEMORAL COMPONENTS AND RP REVISION INSERT WERE REMOVED. THE RP REVISION TIBIA WAS NOT LOOSE AND STAYED IMPLANTED. NO COMPLICATIONS OR DELAYS IN SURGERY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23633534 ↗
• InjuryJan 13, 2025Adverse 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 THE PAINFUL TKA. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21139445 ↗
• InjuryJan 13, 2025Adverse 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 THE PAINFUL TKA. SURGICAL DELAY WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 21139443 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTED KNEE. DOI: (B)(6) 2024; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20352319 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT ATTUNE REVISION REMOVAL DUE TO A POST OP FIXED FLEXION DEFORMITY FROM THE ORIGINAL REVISION SURGERY ON THE (B)(6) 2021 WITH A FOLLOWING SURGERY FOR A POLY REVISION ALSO DONE ON (B)(6) 2022 TO SEE IF WE DOWNSIZED THE POLY IF THAT WOULD HELP THE DEFORMITY. PATIENT WAS VERY UNHAPPY (ALSO NOT A COMPLIANT PATIENT WITH POST OP RECOVERY).

  Patient problems: Loss of Range of Motion

  MAUDE report 15994877 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF COMPONENTS DUE TO INFECTION, ALL COMPONENTS REMOVED FROM PREVIOUS REVISION CASE DONE ON THE (B)(6) 2020 WHICH WAS THE 2ND STAGE REVISION, 1ST STAGE REVISION COMPLETED ON THE (B)(6) 2019. PRIMARY SURGEON /NAME: (B)(6), PRIMARY SURGERY FACILITY: (B)(6), THIS IS THE 3RD STAGE REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9868231 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF COMPONENTS DUE TO INFECTION, ALL COMPONENTS REMOVED FROM PREVIOUS REVISION CASE DONE ON THE (B)(6) 2020 WHICH WAS THE 2ND STAGE REVISION, 1ST STAGE REVISION COMPLETED ON THE (B)(6) 2019. (B)(6), THIS IS THE 3RD STAGE REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9853009 ↗