BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEFT HIP REJUVENATE NECK

    MDR report key: 2885202 · Received December 17, 2012

    Report

    Report Number
    9616680-2012-01421
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    May 24, 2012
    Report Date
    November 29, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THAT THE PT BROKE HIP IN (B)(6) 2012. PT WAS EXPERIENCING EXTREME PAIN. PT HAD A REVISION WITH A NON-STRYKER HIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention