BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADM BALL IMPACTOR TIP

    MDR report key: 4356550 · Received December 23, 2014

    Report

    Report Number
    0002249697-2014-04945
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    December 5, 2014
    Report Date
    December 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DAMAGE INVOLVING AN ADM IMPACTOR WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL ANALYSIS CONFIRMED THAT THE DEVICE WAS FRACTURED THROUGH THE THREADED HOLE. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NOT RELEVANT TO THE INVESTIGATION. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER COMPLAINTS FOR THE REPORTED LOT. CONCLUSIONS: THIS EVENT WAS PREVIOUSLY INVESTIGATED IN PR AND CAPA. THE ROOT CAUSE WAS DETERMINED TO BE DESIGN.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY OF HIP, THE IMPACTOR TIP USED TO IMPACT THE CUP BROKE OFF. DOCTOR THEN USED ANOTHER ONE. SURGERY WAS COMPLETED WITH NO DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PRIMARY OF HIP, THE IMPACTOR TIP USED TO IMPACT THE CUP BROKE OFF. DOCTOR THEN USED ANOTHER ONE. SURGEY WAS COMPLETED WITH NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848122 ADM BALL IMPACTOR TIP IMPLANT LXH STRYKER ORTHOPAEDICS-MAHWAH G3049089

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other