BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP STEM

    MDR report key: 2943397 · Received January 16, 2013

    Report

    Report Number
    2249697-2013-90150
    Event Type
    Injury
    Date Received
    January 16, 2013
    Date of Event
    January 1, 2011
    Report Date
    December 27, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PT HAS HAD PAIN AT HIP JOINT FOR ONE DAY. PT DOES NOT WANT TO PROVIDE ANY ADDITIONAL INFO AT THIS TIME. SHE DOES NOT WANT TO BE CONTACTED AT THIS TIME. SHE MAINLY HAD QUESTIONS ABOUT THE RECALL. SHE WILL SEE HER SURGEON AND MAY CALL BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23930 UNKNOWN HIP STEM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other