BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9

    MDR report key: 2801457 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01860
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 1, 2011
    Report Date
    September 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS 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

    ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # NLV-300800Y LOT # 24945202 DESCRIPTION: REJUVENATE MODULAR NECK, CAT # UH1-48-26 LOT # MHRREM DESCRIPTION: UHR BIPOLAR 26X48MM, CAT # 6260-9-126 LOT # 32933402 DESCRIPTION: 26MM STD LFIT V40 HEAD. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT BEGAN EXPERIENCING PAIN AND DISCOMFORT APPROX ONE YR AGO. SHE STATES THAT SHE HAS PAIN IN HER RIGHT HIP AFTER WALKING MORE THAN THREE BLOCKS. SHE SAW HER DOCTOR IN (B)(6) 2011 AND X-RAYS WERE TAKEN. THE PT STATED THAT HER DOCTOR SAID THERE WAS A POSSIBILITY THAT THE IMPLANT MIGHT BE LOOSE OR THAT HER PAIN WAS CAUSED BY ARTHRITIS. SHE SAYS, THE DOCTOR TOLD HER TO MONITOR HER HIP PAIN AND RETURN TO HIM IF THE PAIN PERSISTED. NO ADD'L TREATMENT WAS PRESCRIBED. SHE SAYS THAT SHE IS ALREADY TAKING PRESCRIPTION PAIN MEDICATION FOR OTHER CONDITIONS. SHE STATES THAT HER PAIN MEDICATION LESSENS BUT DOES NOT ELIMINATE THE PAIN IN HER HIP. THE PT HAS NOT YET SCHEDULED AN APPOINTMENT WITH HER SURGEON BUT SAYS SHE WILL DO SO IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9 UNKNOWN MEH STRYKER ORTHOPAEDICS MAHWAH NA L60MMD

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other