BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT STEM

    MDR report key: 2884984 · Received December 12, 2012

    Report

    Report Number
    9616680-2012-01342
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    February 6, 2012
    Report Date
    November 27, 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
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG AND LOT NUMBER ALONG WITH THE DEVICE WERE NOT PROVIDED FOR INVESTIGATION. THE EVENT WAS CONFIRMED. A VOLUNTARY RECALL RA 2012-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED EVENT IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS EXPERIENCING PAIN WHEN WALKING OR EVEN JUST STANDING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN WHEN WALKING OR EVEN JUST STANDING. ADDITIONAL INFORMATION RECEIVED: PLAINTIFF ALLEGES THE RIGHT REJUVENATE HIP IMPLANTED ON (B)(6) 2012 FAILED CAUSING PAIN AND ELEVATED METAL ION LEVELS. PLAINTIFF HAS NOT YET SCHEDULED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN RIGHT STEM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other