BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT 10° X3 INSERT 36MM ID

    MDR report key: 2913981 · Received January 14, 2013

    Report

    Report Number
    0002249697-2013-00041
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE LIMITED INFORMATION WAS PROVIDED FOR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON DID A TRIAL FOR A CUP AND INSERT AND SEEMED STABLE. ONCE IT WAS IMPLANTED IN THE PATIENT, THE SURGEON DID NOT LIKE THE STABILITY. HE TOOK OUT THE INSERT AND REMOVED CUP AND USED REPLACEMENT INSERT TO COMPLETE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON DID A TRIAL FOR A CUP AND INSERT AND SEEMED STABLE. ONCE IT WAS IMPLANTED IN THE PATIENT, THE SURGEON DID NOT LIKE THE STABILITY AS MUCH. HE TOOK OUT THE INSERT AND REMOVED CUP AND USED REPLACEMENT INSERT TO COMPLETE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21607 TRIDENT 10° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLK9KR

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other