BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIPSTAR MODULAR BROACH HA

    MDR report key: 1933267 · Received December 15, 2010

    Report

    Report Number
    9616680-2010-00824
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME EVENT AS MFR# 9616680-2010-00825.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "BROACHING FOR HIPSTAR STEM AND ADAPTER BROKE. USED A BACKUP ADAPTER AND IT BROKE. FINISHED SURGERY WITH HAND IMPACTOR BROACH HANDLE. NO DELAYS, NO COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIPSTAR MODULAR BROACH HA INSTRUMENT LXH STRYKER ORTHOPAEDICS CORK NA G2685452

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other