BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/48

    MDR report key: 3181329 · Received June 21, 2013

    Report

    Report Number
    0002249697-2013-02010
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A RESTORATION ADM LINER, A MDM LINER AND A METAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF AN MDM LINER. WHEN SURGEON GOT IN THE MECHANISM WAS DISARTICULATED. THE SMALL HEAD CAME OUT OF THE LINER. THIS PATIENT IS A CHRONIC "DISLOCATER." TRIED TO PUSH THE HEAD BACK IN THE POLY AND DIDN'T GO. SURGEON COMMENTED THAT A LARGE FORCE MAY HAVE TORE HEAD OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A REVISION OF AN MDM LINER. WHEN SURGEON GOT IN THE MECHANISM WAS DISARTICULATED. THE SMALL HEAD CAME OUT OF THE LINER. THIS PATIENT IS A CHRONIC DISLOCATER. TRIED TO PUSH THE HEAD BACK IN THE POLY AND DIDN'T GO. SURGEON COMMENTED THAT A LARGE FORCE MAY HAVE TORE HEAD OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282073 RESTORATION ADM X3 INS 28/48 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 40687201

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R