BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM

    MDR report key: 1850360 · Received September 20, 2010

    Report

    Report Number
    2249697-2010-01244
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 26, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "HE REAMED TO 51 TO USE 52 CUP. TRIED TO IMPACT INTO ACETABULUM, AND IT WOULD NOT GRIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MJE15Y

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention