BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI SOLIDBACK CUP 56MM

    MDR report key: 1900023 · Received November 9, 2010

    Report

    Report Number
    2249697-2010-01493
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 MFR. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CAT# 625-0T-32E, LOT# 26300101, DESCRIPTION: RESTORATION GAP II ACET SHELL. CAT# 6565-0-132, LOT# 27836304, DESCRIPTION: ALUMINA V40-FEMORAL HEAD 32MM, +0MM NK. CAT# 6021-0335, LOT# 29524606, DESCRIPTION: ACCOLADE PLUS TMZF HIP STEM #3. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "INFECTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI SOLIDBACK CUP 56MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MHAM4B

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R