BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK

    MDR report key: 3233241 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02363
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K023901
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING FRACTURE INVOLVING A ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS. A MATERIAL ANALYSIS CONCLUDED NO MATERIAL OR MANUFACTURING DEFECTS OBSERVED. MEDICAL RECORDS RECEIVED AND EVALUATION. A REVIEW OF THE PROVIDED X-RAYS AND MATERIAL ANALYSIS REPORT INDICATED, ¿AS NOTED IN THE MATERIAL ANALYSIS REPORT, THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC MANUFACTURING OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION.¿ DEVICE HISTORY REVIEW. NOT PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. COMPLAINT HISTORY REVIEW NOT PERFORMED AS THE DEVICE WAS NOT PROPERLY IDENTIFIED. A MATERIAL ANALYSIS REPORT CONCLUDED THAT THE LACK OF A CONTINUOUS METAL TRANSFER RING AROUND THE PROXIMAL END OF THE TAPERED SURFACE OF THE RETURNED FRAGMENTS OF THE HEAD INDICATE THAT THE HEAD MAY NOT HAVE BEEN PROPERLY SEATED ON THE STEM LEADING TO THE FRACTURE. HOWEVER, DESPITE THESE FINDINGS, THE POST FRACTURE DAMAGE TO THE FRACTURE SURFACES OF THE ALUMINA FEMORAL HEAD OBSCURED ALL FEATURES OF INTEREST, PREVENTING FURTHER ANALYSIS. THERE WAS NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS OBSERVED ON THE RETURNED PRODUCTS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEFT HIP REVISION DUE TO FRACTURED CERAMIC HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEFT HIP REVISION DUE TO FRACTURED CERAMIC HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332869 ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| O| R