BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM

    MDR report key: 2821404 · Received October 23, 2012

    Report

    Report Number
    2249697-2012-02002
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: ACCOLADE TMZF HIP STEM #2, CAT# 6020-0230, LOT# 35863302; TRIDENT 0DEG X3 INSERT 36MM ID, CAT# 623-00-36E, LOT# MKR494; V40 COCR LFIT HEAD 36MM/0, CAT# 6260-9-136, LOT# MLJ8M7; 6.5 CANCELLOUS BONE SCREW 25MM. CAT# 2030-6525-1, LOT# MLJDE1; ACETABULAR DOME HOLE PLUG, CAT# 2060-0000-1, LOT# MLHT1N. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S RASH AND HIVE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COMPLAINS OF RASH AND HIVE, PATIENT HAS SEEN ALLERGISTS AND ALL SAY NOT RELATED TO IMPLANTS, BUT PATIENT IS STILL GETTING HIVES AND RASHES.

    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 MLD33N

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other