BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1498092 · Received September 3, 2009

    Report

    Report Number
    9610726-2009-00180
    Event Type
    Malfunction
    Date Received
    September 3, 2009
    Date of Event
    August 5, 2009
    Report Date
    August 5, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. AND WAS CLEARED (B) (4). AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY, THE CEMENT SET TOO QUICKLY (WITHIN 8 MINUTES), AS A RESULT THE PATELLA # 3 INTENDED TO BE USED COULD NOT BE USED. PATELLA # 5 WAS USED INSTEAD WITH ANOTHER NEW SIMPLEX. THE MIXING TIME WAS 3 MINUTES. THE CEMENT HAD BEEN STORED IN A REFRIGERATOR AT THE HOSP AT THE TEMP OF 10C AND IT WAS TAKEN OUT 10 MINUTES PRIOR TO USE. NO ANTIBIOTIC WAS MIXED WITH THE CEMENT. THE MIXING COMPONENT FROM ZIMMER WAS USED. THE OR TEMP WAS AT 23C. THE SURGEON IS VERY EXPERIENCED (APPROX. 70 CASES PER YR) WITH THE SURGICAL TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other