BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN 52MM PCA CUP

    MDR report key: 2221512 · Received August 11, 2011

    Report

    Report Number
    2249697-2011-01186
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER DEVICES LISTED IN THIS REPORT: DESCRIPTION: UNK POLY INSERT 32 MM, (CAT # AND LOT # UNK), UNK FEMORAL HEAD +5 32MM METAL HEAD (CAT # AND LOT # UNK). IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. THE DEVICES AND ADD'L MEDICAL INFO ARE NOT AVAILABLE FOR EVAL. PAIN IS A SYMPTOM OF A COMPLICATION. IN THIS EVENT, THE COMPLICATIONS ARE UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT WAS COMPLAINING OF PAIN SO THE SURGEON REVISED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN 52MM PCA CUP IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R