ATTUNE 1516-20-514Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295045700), received between Jun 29, 2018 and Jul 8, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR INSTABILITY. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2020. AFFECTED SIDE: RIGHT KNEE. TREATMENT: REVISION, INSERT WAS REMOVED. DEPUY PRODUCTS: CATALOG ID: 150400225; LOT ID: 8572102; COMPONENT TYPE: FEMORAL; DESCRIPTION: ATTUNE C/RET FEM RT SZ 5 NARROW CEMENTED. CATALOG ID: 150670004; LOT ID: 8648915; COMPONENT TYPE: TIBIAL; DESCRIPTION: ATTUNE FB CEMENTED TIBIAL BASE SIZE 4. CATALOG ID: 151820038; LOT ID: 8641265; COMPONENT TYPE: PATELLAR; DESCRIPTION: ATTUNE MEDIAL DOME PAT 38MM. CATALOG ID: 151620514; LOT ID: J7644F; COMPONENT TYPE: INSERT; DESCRIPTION: ATTUNE CR/FB INSERT SZ 5 14MM. COMPETITOR CEMENT USED. INSERT WAS REMOVED.

  Patient problems: Joint Laxity; Pain; Synovitis

  MAUDE report 14958109 ↗
• InjuryDec 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018: THE PATIENT UNDERWENT A 2ND RIGHT KNEE REVISION DUE TO RECURRENT POLYETHYLENE DISSOCIATION. THE SURGEON INDICATED THE LINER WAS FOUND WITHIN THE SUPRAPATELLAR POUCH. HE REPORTED THE TIBIAL AND FEMORAL COMPONENTS AND CEMENT WERE REMOVED WITH OSTEOTOMES AND CEMENT REMOVAL TOOLS. HE NOTED THE TIBIAL COMPONENT HAD LOOSENED BETWEEN THE CEMENT AND COMPONENT INTERFACE. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM. COMPETITOR¿S CEMENT WAS UTILIZED, AND THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Code Available

  MAUDE report 9489077 ↗
• InjuryJun 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED TO ADDRESS DISSOCIATED TIBIAL INSERT. DISSOCIATED TIBIAL INSERT TWICE: ONCE AFTER THE PRIMARY AND AGAIN AFTER THE FIRST REVISION/INSERT EXCHANGE. DOI: (B)(6) 2017. DOI: (B)(6) 2018 ( INSERT AND TRAY ) . DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7649826 ↗