BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE MODULAR NECK

    MDR report key: 2910425 · Received January 8, 2013

    Report

    Report Number
    9616680-2013-90073
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    November 15, 2010
    Report Date
    December 19, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAS EXPERIENCED A DULL PAIN FOR THE LAST FEW MONTHS IN THE HIP JOIN THAT RADIATES DOWN THE BACK OF HER THIGH. PT STATES THAT SHE HAS SEEN HER SURGEON AND HAD X-RAYS DONE. PT ALSO STATES THAT THE SURGEON HAS ORDERED BLOOD WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10283 REJUVENATE MODULAR NECK IMPLANT MEH STRYKER ORHTOPAEDICS CORK NA 31643402

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other