BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 36MM ID US CRMC LINER 54

    MDR report key: 2771097 · Received October 3, 2012

    Report

    Report Number
    8010764-2012-00041
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    PMA / PMN Number
    P030022/S008
    Removal / Correction Number
    Z-2053-2058-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ASSOCIATED DEVICES WERE RETURNED AND EVALUATED. THE RETURNED BIOLOX FORTE (ALUMINA) FEMORAL HEAD AND R3 BIOLOX FORTE (ALUMINA) LINER WERE EXAMINED VISUALLY. THE PURPOSE OF THIS INVESTIGATION WAS TO ANALYZE THE AS-RECEIVED COMPONENTS. NO DESTRUCTIVE TESTING WAS CARRIED OUT. THE ARTICULATING SURFACE OF THE ALUMINA FEMORAL HEAD HAD VISIBLE SIGNS OF METAL TRANSFER. THE ACETABULAR LINER WAS FRACTURED INTO SEVERAL FRAGMENTS WHICH CONSISTED OF THE APEX REGION AND THE RING PORTION OF THE LINER. THE RING PORTION OF THE LINER HAD VISIBLE SIGNS OF DAMAGE TO THE TAPER REGION OF THE RING AND METAL TRANSFER. THE SIGNS OF DAMAGE AND METAL TRANSFER WERE LIKELY DUE TO EXTRACTION, CONTACT WITH OTHER COMPONENTS DURING REMOVAL, AND/OR CONTACT WITH OTHER COMPONENTS FOLLOWING FRACTURE OF THE LINER. THERE WERE NO MANUFACTURING OR MATERIAL ISSUES NOTED WITH THIS EVALUATION. THE SHATTERED LINER HAS BEEN IDENTIFIED AS BEING ASSOCIATED WITH A PREVIOUS RECALL LAUNCHED IN 2011. NO ADDITIONAL ACTIONS ARE BEING TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R3 36MM ID US CRMC LINER 54 ACETABULAR LINER JDH SMITH & NEPHEW, INC. 09ET32145

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R