BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA C-TAPER HEAD 32MM/-2.5

    MDR report key: 1942457 · Received December 22, 2010

    Report

    Report Number
    9616680-2010-00855
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K003391
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENT REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 6020-0537, LOT# 31082801, DESCRIPTION: ACCOLADE TMZF HIP STEM #5. CAT# 625-0T-32F, LOT# 29983701, DESCRIPTION: TRIDENT ALUMINA INSERT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PATIENT PRESENTED TO SURGEON WITH PAINFUL HARDWARE. SURGEON RECOMMENDATIONS WERE A REVISION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA C-TAPER HEAD 32MM/-2.5 IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention