BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2690678 · Received August 7, 2012

    Report

    Report Number
    2249697-2012-01109
    Event Type
    Injury
    Date Received
    August 7, 2012
    Date of Event
    July 12, 2012
    Report Date
    July 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: LRG TAP PRI MOD NCK 8 DEG 34MM, CAT# NLV-340800G, LOT# 35231101. V40 COCR LFIT HEAD 36MM/+5, CAT# 6260-9-236, LOT# MKEN4L. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S NON UNION OF THE PERI PROSTHETIC FRACTURE. AN EVALUATION OF THE REPORTED DEVICES CANNOT BE PERFORMED AS THE DEVICES WERE SENT TO THE HOSPITAL'S PATHOLOGY LAB PER THEIR PROTOCOL AND WILL BE DESTROYED. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PT RETURNED TO OFFICE ON (B)(6) /2012 COMPLAINING OF THIGH PAIN. X-RAY WAS TAKEN AND REVEALED A BROKEN PLATE AT THE PREVIOUS FX SITE DUE TO A NON UNION OF THE PERI-PROSTHETIC FX. REJUVENATE STEM AND NECK AND V40 HEAD WERE REMOVED. SMITH NEPHEW REVISION STEM WAS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention