ATTUNE 1516-50-912Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295053033), received between Oct 8, 2019 and Aug 14, 2023 — classified as 2 injuries.

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 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRODUCTS WERE EXPLANTED DUE TO INFECTION TO THE RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 17540481 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED 17 JUNE 2019 AND WERE REVIEWED 16 SEPTEMBER 2019 FOR MDR REPORTABILITY. ON (B)(6) 2017, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO END-STAGE PRIMARY OSTEOARTHRITIS OF THE LEFT KNEE. IT WAS NOTED THE PATELLA WAS RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE. COMPETITOR¿S CEMENT WAS IMPLANTED IN THE PROCEDURE. ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO STIFFNESS, WITH REVISION OF THE TIBIAL INSERT. THE SURGEON REPORTED A LOT OF SCAR TISSUE THAT WAS RESECTED OUT. HE THEN REPORTED THE REMOVAL OF THE POLYETHYLENE LINER. THERE WERE NO COMPLAINTS REGARDING THE PATELLA, FEMORAL COMPONENT, NOR THE TIBIAL COMPONENT, AND THESE WERE NOT REVISED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ATTUNE TIBIAL INSERT WAS IMPLANTED IN THE PROCEDURE. DOI: (B)(6) 2017, DOR: (B)(6) 2017 (LT KNEE).

  Patient problems: No Code Available; Scar Tissue

  MAUDE report 9167418 ↗