BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 32MM ID US CRMC LINER 50

    MDR report key: 3921569 · Received July 9, 2014

    Report

    Report Number
    8010764-2014-00031
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    January 15, 2013
    Report Date
    July 1, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LZO
    PMA / PMN Number
    P030022/S008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ASSOCIATED DEVICES WERE RETURNED AND EVALUATED. FOUR FRAGMENTS AS WELL AS THE APEX REGION WERE RECEIVED. THE RIM REGION AND THE CERAMIC HEAD WERE ALSO RECEIVED. AN ASSESSMENT BY OUR RESEARCH DEPARTMENT CONCLUDED THE FOLLOWING: METAL TRANSFER AND STRIPE-WEAR FEATURES CHARACTERIZED BY INTER-GRANULAR FRACTURE/GRAIN-PULLOUT WERE OBSERVED ON THE ALUMINA HEAD. COMPOSITIONAL ELEMENTS OF TI6AL4V WERE IDENTIFIED ON THE SURFACE OF THE FEMORAL HEAD USING SEM/EDAX; THIS TRANSFER WAS LIKELY CAUSED BY CONTACT WITH THE SHELL. SIGNS OF BURNISHING, STRIPE WEAR FEATURES, DEFORMATION, AND METAL TRANSFER WERE OBSERVED ON THE RIM REGION OF THE ACETABULAR LINER. COMPOSITIONAL ELEMENTS OF TI6AL4V WERE IDENTIFIED ON THE SURFACE OF THE RIM REGION OF THE ACETABULAR LINER USING SEM/EDAX; THIS TRANSFER WAS LIKELY CAUSED BY CONTACT WITH THE ALUMINA FEMORAL HEAD. INTER-GRANULAR FRACTURE AND GRAIN-PULLOUT ARE INDICATIVE OF HIGH CONTACT STRESSES POSSIBLY CAUSED BY CONTACT BETWEEN THE HEAD AND EDGE OF LINER. SIMILAR STRIPE-WEAR FEATURES HAVE BEEN REPORTED IN THE LITERATURE FOR RETRIEVED ALUMINA DEVICES. THE BURNISHING, DEFORMATION, AND METAL TRANSFER OBSERVED ON THE RIM REGION OF THE ACETABULAR LINER WERE LIKELY DUE TO DISLOCATION OR IMPINGEMENT CONTACT BETWEEN THE FEMORAL HEAD AND/OR FEMORAL STEM NECK AND THE METAL RING OF THE ACETABULAR LINER. ROOT CAUSE REMAINS UNKNOWN. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY MATERIAL OR MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PREFORMED DUE TO SQUEAKING NOISE EMITTING FROM THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401236 R3 32MM ID US CRMC LINER 50 CERAMIC FEMORAL LINER LZO SMITH & NEPHEW, INC. 08GT22378

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R (B)(4) - ANTHOLOGY HO PO PL HA SZ 3 - (B)(4)| (B)(4) - BIO FORTE CER 32 HD 12/14 +0 - (B)(4)