BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM

    MDR report key: 1631024 · Received March 9, 2010

    Report

    Report Number
    2249697-2010-00269
    Event Type
    Injury
    Date Received
    March 9, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 10, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADD'L INFO PERTAINING INCLUDING X-RAYS AND MEDICAL RECORDS WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ABOVE LISTED WERE IMPLANTED ON (B) (6) 2009 IN A REVISION ON AN EXISTING ACCOLADE STEM (IMPLANTED (B) (6) 2003). THE TRITANIUM CUP WAS LOOSE AND PAINFUL AND ALL OF THE ABOVE WERE REMOVED. ACETABULAR COMPONENTS FROM ANOTHER VENDOR WERE IMPLANTED ALONG WITH A 17-0000E V40/C-TAPER ADAPTER SLEEVE (LOT W6VMMD) AND 18-3675 BIOLOX C-TAPER HEAD 36MM +7.5 (LOT 13929903). ALSO NOTED IS THAT 10CC OF OSTEOMATRIX BONE GRAFT MADE BY BIOSTRUCTURE WAS IMPLANTED ON (B) (6) 2009 FOR A MEDIAL WALL DEFECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MERP2R

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention