ATTUNE 1516-50-816Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295052913), received between Oct 29, 2019 and Feb 3, 2026 — 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 16, 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.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATELLA WAS LOOSE AND UNSTABLE. NEW PATELLA AND V/V CONSTRAINING INSERT.

  Patient problems: Joint Laxity

  MAUDE report 24244465 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PAINFUL TOTAL KNEE ARTHROPLASTY. DOI: (B)(6) 2022, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 23795257 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT HAD A REVISION RIGHT TOTAL KNEE ARTHROPLASTY, ENTIRE FEMORAL AND TIBIAL COMPONENT TO ADDRESS PAINFUL RIGHT KNEE ARTHROPLASTY WITH OSTEOLYSIS. DURING THE REVISION, THE SURGEON NOTED A FAIR AMOUNT OF BONE LOSS AROUND THE TIBIAL SIDE ALSO SOME MICRO MOTION ON THE TIBIAL SIDE. THE LOOSENING WAS NOTED AT THE BONE/CEMENT INTERFACE OF THE TIBIAL SIDE. THE FEMORAL SIDE WAS NOTED TO BE WELL FIXED, BUT WAS REVISED NONETHELESS. THE PATELLA COMPONENT WAS WELL FIXED AND NOT REVISED. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS REVISION. DOI: (B)(6) 2016 (FEMUR), DOI: (B)(6) 2019 (TIBIA, INSERT AND PATELLA - FIRST REVISION CAPTURED IN (B)(4)), DOR: (B)(6) 2020.

  Patient problems: Osteolysis; Pain

  MAUDE report 11046346 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RT TKA DONE A NUMBER OF YEARS AGO WITH A COMPETITOR. THE PATIENT FELL AND THEN HAD A FEMUR FRACTURE. THEN THE PATIENT DEVELOPED A KNEE INFECTION. THE SURGEON REMOVED THE COMPETITOR KNEE AND HARDWARE AND PUT IN A SPACER. IT WAS THEN ON (B)(6) 2019 THAT THE SURGEON USED DEPUY TO REVISE THE SPACER WITH ATTUNE REVISION AND THE FINAL RESULT WAS VERY GOOD. HOWEVER, OVER THE PAST MONTH, THIS PATIENT HAD BEEN COMPLAINING OF AN UNSTABLE FEELING WHEN BENDING HIS KNEE IN FLEXION. THE SURGEON SAW THE PATIENT IN THE CLINIC AND SAID THAT THE PATIENTS FLEXION GAP HAD INCREASED OVER TIME AND THE PATIENT STILL HAD FLEXION STABILITY. THE SURGEON WANTED TO DO A POLY EXCHANGE AND A TAKE OUT OF THE STABILIZED RP INSERT AND PUT IN A CRS INSERT ALONG WITH INCREASING IT'S THICKNESS. HE ALSO WAS READY TO REVISE THE ENTIRE FEMUR IF NECESSARY. THE SURGEON OPENED THE PATIENT UP AND REMOVED THE POLY. TRIALING WAS DONE WITH A 20 CRS POLY. THE KNEE WAS STILL ABLE TO GET EXTENSION AND FLEXION INSTABILITY WAS SOLVED BY GOING UP FROM A 16MM PS RP TO A 20 MM CRS RP. THE SURGEON THEN CLOSED THE KNEE. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9249576 ↗