BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SELZACH_PRODUCT

    MDR report key: 4792716 · Received May 22, 2015

    Report

    Report Number
    0008031020-2015-00199
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 27, 2015
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION (CATALOG NUMBER, LOT NUMBER, X-RAYS, ETC.) WAS PROVIDED. WITH THE GIVEN INFORMATION, IT WAS NOT POSSIBLE TO DO ROOT CAUSE. HOWEVER, BASING ON THE FEW PROVIDED INFORMATION AND TO THE INVESTIGATION, IT IS LIKELY THAT THE REPORTED PAIN AT PATIENTS' ACETABULUM OCCURRED BECAUSE OF NONOBSERVANCE OF POSTOPERATIVE INSTRUCTIONS AND WARNINGS BY THE PATIENT (E.G. PATIENT LOADED ALL FULL LOAD ACUTELY) AND/OR BECAUSE THE SURGEON DID NOT COUNSEL THE PATIENT ON CORRECT BEHAVIOR AND ACTIVITY AFTER IMPLANTATION. NONETHELESS, MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE OPENED. UNKNOWN ASNIS SCREWS. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ACETABULUM PAIN. PATIENT DECIDED TO MOVE TO TOTAL HIP. NOTHING FAILED OR BROKE. THE SURGEON REMOVED THREE 6.5 ASNIS SCREWS TO CONVERT TO A TOTAL HIP REPLACEMENT. NOTHING FAILED OR BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334137 UNKNOWN_SELZACH_PRODUCT IMPLANT JDI STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention