ATTUNE 1516-51-005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295053125), received between Dec 19, 2019 and Oct 4, 2023 — 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.

• InjuryOct 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE WAS THE LEFT KNEE.

  Patient problems: Muscular Rigidity

  MAUDE report 17868540 ↗
• InjuryJul 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE REVIEWED ON AD (B)(6) 2020 BY A CLINICIAN TO IDENTIFY PATIENT HARMS/PRODUCT ISSUES. PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT SEVERE DEGENERATIVE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED AND COMPETITOR CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT REVISION OF THE INSERT, FEMORAL COMPONENT, AND TIBIAL TRAY TO TREAT UNSPECIFIED MECHANICAL LOOSENING. THE PATELLA WAS RETAINED. REVISION OPERATIVE NOTES WERE NOT PROVIDED. DOI: (B)(6) 2015; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Adhesion(s); Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10225871 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. I&D AND POLY SWAP WERE PERFORMED. DOI: (B)(6) 2019; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9538372 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS, AND PAIN. THE SURGEON REPORTED A LOT OF SCAR TISSUE AROUND THE PATELLA AND PATELLAR TENDON. HE INDICATED THE KNEE WAS VERY STIFF AND DIFFICULT TO FLEX UP. THE SURGEON REPORTED THE FEMORAL COMPONENT WAS FOUND TO BE VERY LOOSE AND TAMPED OFF WITH NO BONE LOSS. THERE WAS NO ADHERENCE AT THE FEMORAL COMPONENT TO CEMENT INTERFACE. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS COMPLETELY LOOSE AT THE COMPONENT TO CEMENT INTERFACE. HE NOTED THE PATELLA WAS FOUND TO BE PLACED LATERAL AND WITH SOME WEAR, AND REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. TWO DEPUY CEMENT PRODUCTS WERE USED DURING PRIMARY OPERATION. PLEASE ADD HOSPITAL ACCOUNT INFORMATION. AWARENESS DATE IS 03 DECEMBER 2019.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9497242 ↗