ATTUNE 1517-10-814Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295056270), received between Feb 12, 2019 and Aug 14, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50260198 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD I&D FOR SUSPECTED INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2026. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25057172 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD WASHOUT AND POLY SWAP. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23991482 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A POLY SWAP WASHOUT FROM A TKA REV DONE 3 WEEKS AGO. PATIENT WAS DRAINING CONSISTENTLY SO THE SURGEON FOUND IT BEST TO OPEN THE JOINT, WASH THE JOINT OUT, PUT ANTIBIOTIC BEADS AND SWAP THE POLY FOR THE SAME SIZE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fluid Discharge

  MAUDE report 19459814 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: INFECTION, PAIN & LOOSENING.

  Patient problems: Joint Laxity; Pain; Unspecified Infection

  MAUDE report 18962041 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. NO BROKEN PIECES. DOI- UNKNOWN. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16914720 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A WASHOUT. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16395926 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED INDICATED THAT THE PRIMARY OPERATIVE NOTES AND THE FIRST REVISION PROCEDURE NOTES WERE NOT PROVIDED WITHIN THIS SET OF MEDICAL RECORDS. IT IS UNKNOWN, AT THIS TIME, WHAT THE MANUFACTURER OF THE PRIMARY IMPLANTS OR FIRST REVISION SURGERY WERE. UNKNOWN IF DEPUY ¿ DATES OF PRIMARY AND FIRST REVISION SURGERIES ALSO NOT PROVIDED. REVISION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INFECTION. IT IS UNKNOWN IF DEPUY PRODUCTS WERE IMPLANTED AT THIS SURGERY. RE-IMPLANTATION OPERATIVE NOTES (B)(6) 2019 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE RE-IMPLANTATION DUE TO INFECTION MARKERS WERE SATISFACTORY FOR RE-IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO INFECTION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. (B)(4). REVISION OPERATIVE NOTES (B)(6) 2021 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION DUE TO PAIN, SWELLING AND HEMATOGENOUS SPREAD OF INFECTION. THE SURGERY WAS COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURG

  Patient problems: Unspecified Infection

  MAUDE report 12705737 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4). THE PATIENT WAS REVISED DUE TO INFECTION. EVERYTHING WAS REMOVED AND STAGE ONE SPACER IMPLANTED. NO LOOSENING AND SURGICAL DELAY NOTED. DOI: (B)(6) 2019. DOR: (B)(6) [201]. LEFT KNEE.

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

  MAUDE report 12438708 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. KNEE WAS WASHED OUT AND POLY WAS EXCHANGED. NO SURGICAL DELAY. DOI: (B)(6) 2021. DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 11619620 ↗
• InjuryFeb 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS SPIN OUT.

  Patient problems: No Code Available

  MAUDE report 8331681 ↗