BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER 2.5 I M PLUG 16MM

    MDR report key: 1706947 · Received May 26, 2010

    Report

    Report Number
    9610726-2010-00170
    Event Type
    Malfunction
    Date Received
    May 26, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LZN
    PMA / PMN Number
    K980843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ITEM WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "EXETER BONE PLUG CEMENT RESTRICTOR CRACKED ON INSERTION INTO FEMORAL CANAL. SURGEON WAS A LITTLE SURPRISED THAT IT CRACKED. ITEM WAS USED CORRECTLY DURING THE CASE, ALTHOUGH HE DID MAKE COMMENT THAT IT WAS PROBABLY A 15 MM, SO HE WENT WITH A 16 MM PLUG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER 2.5 I M PLUG 16MM IMPLANT LZN STRYKER ORTHOPAEDICS LIMERICK NA L4992

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other