ATTUNE 1516-40-307Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295049661), received between Nov 6, 2017 and Aug 27, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Disassembly” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K111433, K233980); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 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 INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20076142 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TKP WAS TOO LAX, SO WE CHANGED THE INSERT TO A THICKER ONE. DOI: (B)(6) 2019. DOE: (B)(6) 2024.

  Patient problems: Joint Laxity

  MAUDE report 18595769 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN . DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17215422 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THE SURGEON DECIDED IT BEST TO REMOVE ALL IMPLANTS AND PLACE A SURESPACE SPACER WITH ANTIBIOTIC CEMENT. ALL COMPONENTS WERE REMOVED. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15289701 ↗
• InjuryMay 1, 2018Disassembly; Fracture; Disassembly; Fracture

  THE PRIMARY SURGERY ON (B)(6) 2017. ON (B)(6) 2017, THE SURGEON FOUND THAT THE INSERT WAS DISSOCIATED UNDER X-RAY WHEN THE PATIENT VISITED TO THE HOSPITAL. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 BY REPLACING THE INSERT. AFTER THE REVISION SURGERY, THE SURGEON FOUND THAT THE TAB IN FRONT OF THE INSERT WAS BROKEN. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7475427 ↗
• MalfunctionJan 16, 2018Disassembly; Disassembly

  THE REPORTED IMPLANTS WERE IMPLANTED TO THE PATIENT¿S KNEE JOINT ON (B)(6) 2017. IT WAS REPORTED THAT THE SURGEON RECOGNIZED THAT THE INSERT WAS APPEARED TO BE DISSOCIATED UNDER X-RAY ON (B)(6) 2017. THE SURGEON SUSPECTED THAT THE INSERT WAS NOT LOCKED PROPERLY DURING THE OPERATION. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. DOI: (B)(6) 2017; DOR: UNKNOWN; UNKNOWN KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7194283 ↗
• MalfunctionNov 6, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THE 3/7 POLY WOULD NOT SEAT ON TRAY PROPERLY. MULTIPLE ATTEMPTS FOR APPROX. 10 MINUTES. IT WAS STATED THAT THEY OPENED NEW 3/7 POLY AND IT FIT AS DIRECTED.

  Patient problems: No Information

  MAUDE report 7005402 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111433, K233980. One submission often covers many models, so check the product and lot details in each record.

• Z-1267-2023 · Feb 15, 2023 · Open, Classified
  Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507