BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE MODULAR NECK 34MM

    MDR report key: 2850869 · Received November 20, 2012

    Report

    Report Number
    9616680-2012-01144
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    August 11, 2010
    Report Date
    November 6, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    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 RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING EXTREME PAIN IN HIP AND TENDON. PT HAD MRI AND BLOOD WORK PERFORMED AND IT WAS FOUND THAT PT HAS ELEVATED BLOOD LEVELS. PT HAD A PARTIAL HIP REPLACEMENT ON (B)(6) 2012, ALONG WITH TENDON REPAIR. PT STATES THAT TENDON DAMAGE WAS DONE DUE TO ORIGINAL IMPLANT. PARTIAL IMPLANT REPLACEMENT WAS PERFORMED AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE MODULAR NECK 34MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention