BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX ABC CE MARK 1 PCK

    MDR report key: 2255054 · Received September 15, 2011

    Report

    Report Number
    9610726-2011-00318
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 31, 2011
    Report Date
    August 31, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. 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

    IT WAS REPORTED, PHARMACIST AT THE HOSPITAL REPORTED THAT DURING THE IMPLANTATION OF A SHOULDER IMPLANT, THE CEMENT BECAME HARD IN LESS THAN 3 MINS (INSTEAD OF 15 MINS). "THE SURGEON HAD TO START THE SURGERY AGAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX ABC CE MARK 1 PCK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA BDS015

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention