ATTUNE 1516-50-818Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295052920), received between Aug 19, 2020 and Aug 30, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD EXPLANT AND IMPLANT OF AN ANTIBIOTIC SPACER. DOI: (B)(6) 2023. DOR: (B)(6), 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17650359 ↗
• InjuryAug 19, 2020Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT HAD A LEFT TKA REVISION PERFORMED ON (B)(6) 2019. SURGEON INFORMED THE SALES REP. THAT PATIENT DIDN'T GO A VERY GOOD JOB ON HIS REHAB AND WAS UNABLE TO GET THE KNEE INTO FULL EXTENSION NOW. SURGEON WANTED TO DO A POLY SWAP REVISION, DOWNSIZE THE THICKNESS AND DO SOME SOFT TISSUE RELEASES IN ORDER TO GET THE PATIENT BACK INTO FULL EXTENSION. SURGEON REMOVED THE POLY, TRIALED WITH ONE SIZE LOWER AND ALONG WITH SOME SOFT TISSUES RELEASES. WAS ABLE TO GET THE KNEE INTO FULL EXTENSION AND CLOSED. DOI: (B)(6) 2019, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available

  MAUDE report 10426477 ↗