ATTUNE 1516-21-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295046264), received between Jun 21, 2018 and Mar 28, 2019 — classified as 1 injury, 1 malfunction.

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 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.

• MalfunctionMar 28, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ATTUNE OUTSIZER KIT WAS FOUND TO HAVE EXPIRED IMPLANTS IN THE SET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460123 ↗
• InjuryJun 21, 2018Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  RECEIVED MEDICAL RECORDS ON 05/30/2018. RECORDS REVIEWED FOR MDR REPORTABILITY. LEFT ATTUNE KNEE REVISED TO ADDRESS PAIN, PERSISTENT SWELLING, AND GROSS FLEXION INSTABILITY. SURGICAL DIAGNOSIS WAS FAILED LEFT TOTAL KNEE, SECONDARY TO INSTABILITY, MALROTATION, AND TIBIAL BASE PLATE LOOSENING. REVISING SURGEON OBSERVED SYNOVITIS, MALROTATION OF THE TIBIAL TRAY, GROSS LOOSENING/DEBONDING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE, AND LOOSENING OF THE FEMUR COMPONENT AT THE CEMENT TO BONE INTERFACE (FEMUR AND CEMENT CAME LOOSE TOGETHER WITH SIMPLE TAPS OF THE MALLET). THE PATELLA, AND THE TIBIA CEMENT MANTLE, WERE NOTED TO BE WELL-FIXED. TIBIAL INSERT WAS DESCRIBED AS PITTED, BUT NOT DELAMINATED. PATELLA WAS NOT REVISED; OTHERWISE, ALL OTHER DEPUY PRODUCTS REPLACED WITH COMPETITOR PRODUCTS. DOI: (B)(6) 2015; DOR: (B)(6) 2017; (LEFT KNEE).

  Patient problems: Not Applicable; Pain; Swelling

  MAUDE report 7625010 ↗