BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL RADIUS M/S SCREWLESS CUP 50MM

    MDR report key: 3023672 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01092
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K935875
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING IMPLANT MIGRATION INVOLVING AN OMNIFIT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE AS FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    CUP HAD SLID UP TO A VERTICAL POSITION, DR (B)(6) REMOVED IT, LEFT IN STEM AND PUT IN A NEW CUP AND POLY.

    Description of Event or Problem · 1

    CUP HAD SLID UP TO A VERTICAL POSITION, DR. (B)(6) REMOVED IT, LEFT IN STEM AND PUT IN A NEW CUP AND POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125455 DUAL RADIUS M/S SCREWLESS CUP 50MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH SH3060

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention