BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASEPLATE

    MDR report key: 4266571 · Received November 20, 2014

    Report

    Report Number
    0002249697-2014-04367
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    October 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWS
    PMA / PMN Number
    K130895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DIFFICULTY SEATING A REVERSE SHOULDER BASEPLATE AND CENTER SCREW WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PREFORMED AS NO PRODUCTS WERE PROVIDED FOR INSPECTION. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PREFORMED AS PATIENT MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTED EVENTS FOR THIS LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO DEVICE WAS PROVIDED FOR INSPECTION AND NO PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY RIGHT REVERSE SHOULDER ARTHOPLASTY, STRYKER BASEPLATE CENTER SCREW LOCKED INTO THE BASEPLATE BEFORE IT WAS SUFFICIENTLY COMPRESSED INTO THE GLENOID. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMARY RIGHT REVERSE SHOULDER ARTHOPLASTY, STRYKER BASEPLATE CENTER SCREW LOCKED INTO THE BASEPLATE BEFORE IT WAS SUFFICIENTLY COMPRESSED INTO THE GLENOID.THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752614 BASEPLATE IMPLANT KWS STRYKER ORTHOPAEDICS-MAHWAH MNJJWE

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other