BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABGII. FEMORAL STEM WITH HYDROXYAPATITE LEFT N 7

    MDR report key: 2234048 · Received August 29, 2011

    Report

    Report Number
    9616680-2011-00567
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MAY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR.# 9616680-2011-00566. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    SURGEON REPORTED TO REGIONAL SALES MANAGER THAT AN ABGII REVISION SURGERY TOOK PLACE BECAUSE OF THE BREAKAGE OF CERAMIC HEAD, WHICH WAS PLACED IN 2008. HE FURTHER REPORTED THAT AFTER THE INCISION HE ESTABLISHED SO MUCH METALOSIS, THAT THE STEM ALSO HAD TO BE REMOVED AND REPLACED, AS THE NECK OF THE PROSTHESIS WAS TOTALLY DESTROYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABGII. FEMORAL STEM WITH HYDROXYAPATITE LEFT N 7 IMPLANT MAY STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention