BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE PLUS MZF HIP STEM #3

    MDR report key: 2359767 · Received December 1, 2011

    Report

    Report Number
    9616680-2011-00768
    Event Type
    Injury
    Date Received
    December 1, 2011
    Date of Event
    November 18, 2011
    Report Date
    November 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MAX THAT, "ON (B)(6) 2011, UNDERWENT A TOTAL REPLACEMENT OF MY RIGHT HIP AT (B)(6). THE DETAILS OF THE IMPLANTED PROSTHESIS ARE ENCLOSED. ABOUT 4 WEEKS LATER, I SUFFERED A SPONTANEOUS SPIRAL FRACTURE OF THE SHAFT OF MY RIGHT FEMUR BEGINNING AT THE LOWER EDGE OF THE FEMORAL IMPLANT. THIS OCCURRED WHILE I WAS STANDING ON THE DECK OF OUR POOL. IT WOULD BE APPRECIATED IF YOU WOULD REVIEW YOUR RECORDS FOR THE PREVIOUS IMPLANTED IN ME TO INSURE THAT THEY WERE ALL DEFECT FREE AND MET ALL SPECIFICATIONS. I WOULD ALSO APPRECIATE THE MANUFACTURING DATE AND THE DATE OF TRANSFER TO (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE PLUS MZF HIP STEM #3 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 36288405

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR