BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA C-TAPER HEAD 32MM/+5

    MDR report key: 3092289 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01523
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K971409
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING ALLEGED CRACK/FRACTURE INVOLVING A CERAMIC HEAD WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS RECEIVED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, OPERATIVE REPORTS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    PATIENT REPORTED EXTRAORDINARY EVENT WHEN CERAMIC HEAD FRACTURED AND THIS WAS CONFIRMED BY X-RAY AND SCAN. REVISION SURGERY REQUIRED DUE TO FRACTURE OF STRYKER BIOLOX CERAMIC HEAD. BECAUSE OF VERY OBVIOUS WEAR ON NECK OF IMPLANT AND DESTRUCTION OF THE TRUNNION A WELL FIXED SECURFIT STEM NEEDED TO BE REMOVED AND REPLACED BY A DEPUY SROM STEM. THE WELL FIXED ABC CERAMIC CUP AND LINER ALSO REQUIRED TO BE REVISED AND A DEPUY GRIPTION CUP WAS USED FOR THIS PROCEDURE.

    Description of Event or Problem · 1

    PATIENT REPORTED EXTRAORDINARY EVENT WHEN CERAMIC HEAD FRACTURED AND THIS WAS CONFIRMED BY X-RAY AND SCAN. REVISION SURGERY REQUIRED DUE TO FRACTURE OF STRYKER BIOLOX CERAMIC HEAD. BECAUSE OF VERY OBVIOUS WEAR ON NECK OF IMPLANT AND DESTRUCTION OF THE TRUNNION A WELL FIXED SECURFIT STEM NEEDED TO BE REMOVED AND REPLACED BY A DEPUY SROM STEM. THE WELL FIXED ABC CERAMIC CUP AND LINER ALSO REQUIRED TO BE REVISED AND A DEPUY GRIPTION CUP WAS USED FOR THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195097 ALUMINA C-TAPER HEAD 32MM/+5 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 3264G

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| O| R