BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP PLATE SCREWS

    MDR report key: 3781289 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01606
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    October 15, 2013
    Report Date
    April 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K943549
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A GAP PLATE SCREWS WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION INDICATED THAT INSUFFICIENT MEDICAL RECORDS WERE RETURNED FOR EVALUATION. DEVICE HISTORY REVIEW. INDICATED THAT THE SPECIFIED LOT WAS ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. THE REPORTED EVENT INVOLVES ANTERIOR AND MEDIAL DEVIATION OF THE ACETABULAR COMPONENT INTO THE PELVIS AND FRACTURED SCREWS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS PATIENT HISTORY AND OFFICE NOTES WERE NOT MADE AVAILABLE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT # (B)(4) REPORTED RIGHT HIP ARTHROPLASTY FAILURE. X-RAYS OBTAINED APPROXIMATELY TWO MONTHS PRIOR TO EVENT, NOTE AN ANTERIOR AND MEDIAL DEVIATION IF THE ACETABULAR COMPONENT INTO THE PELVIS. BROKEN SCREWS ARE VISUALIZED. THERE DO NOT APPEAR TO BE CONCERNS WITH THE FEMORAL COMPONENT. THERE APPEARS TO BE GOOD BONE IN THE POSTERIOR WALL OF THE PELVIS.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT # (B)(4) REPORTED RIGHT HIP ARTHROPLASTY FAILURE. X-RAYS OBTAINED APPROXIMATELY TWO MONTHS PRIOR TO EVENT, NOTE AN ANTERIOR AND MEDIAL DEVIATION IF THE ACETABULAR COMPONENT INTO THE PELVIS. BROKEN SCREWS ARE VISUALIZED. THERE DO NOT APPEAR TO BE CONCERNS WITH THE FEMORAL COMPONENT. THERE APPEARS TO BE GOOD BONE IN THE POSTERIOR WALL OF THE PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259132 GAP PLATE SCREWS IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MLN3EV

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention