BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2896154 · Received December 27, 2012

    Report

    Report Number
    2249697-2012-02803
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    August 2, 2010
    Report Date
    December 11, 2012
    Manufacturer
    STRYKER ORTHPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT RECEIVED RECALL LETTER IN AUGUST FROM SURGEON. PATIENT STATES THAT SHE DISLOCATED HER HIP AND HAS A TORN TENDON. PATIENT STATES THAT SHE HAS TO SCHEDULE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT MEH STRYKER ORTHPAEDICS MAHWAH NA MJD15P

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other