ATTUNE 1516-50-416Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295052357), received between Jan 20, 2021 and Nov 6, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 29 OCT 2024: IT WAS REPORTED ON (B)(6) 2015: 54-YEAR-OLD FEMALE PATIENT RECEIVED AN ATTUNE RIGHT KNEE TKA TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. REVISION SURGERY OCCURRED (B)(6) 2019: 57-YEAR-OLD FEMALE PATIENT RECEIVED A TOTAL RIGHT KNEE REVISION TO TREAT PAIN, GROSS INSTABILITY, AND LOOSENING OF THE TIBIAL TRAY. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED SCAR TISSUE. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT CEMENT TO IMPLANT INTERFACE WITH MIGRATION INTO VARUS AND EXTENSIVE TIBIAL BONE LOSS, AND REVISED. SURGEONS NOT THERE WAS A PARTIALLY HEALED TIBIAL CONDYLE FRACTURE. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT AND THE PATELLA WAS RETAINED. THE PATIENT RECEIVED A COMPETITOR REVISION CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Adhesion(s); Joint Laxity; Pain

  MAUDE report 20622172 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION STATES THAT THE LEFT SIDE WAS THE OPERATIVE SIDE. THE SPACER WAS REVISED TO TREAT AN ONGOING INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20174635 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SITE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16409536 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. IN THE DER, LOOSENING WAS MARKED AS "YES" OF THE FEMORAL COMPONENT BUT THE INTERFACE WAS MARKED AS "NOT APPLICABLE". PLEASE VERIFY IF THERE WAS REALLY LOOSENING. IF YES, AT WHAT INTERFACE DID THE LOOSENING OCCUR? B. PLEASE CLARIFY WHAT "LIGAMENT LOOSENING ISSUE" MEANS. WAS THE KNEE BECAME UNSTABLE OR THIS MEANS LOOSENING OF THE FEMORAL COMPONENT? C. PLEASE CONFIRM IF THERE WERE ANY DEPUY INSTRUMENTATION THAT BROKE DURING SURGERY? IF YES, PLEASE PROVIDE THE DETAILS. ANSWER: YES THE LIGAMENTS WERE UNSTABLE BC OF THE FALL/FALLS PER THE DOCTOR. THE FEMUR COMPONENT WAS NOT LOOSE ON THE INTERFACE OR LOOSE. I MAY HAVE MISS MARKED THAT. NO INSTRUMENTS WERE BROKE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 11200918 ↗