BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 30MM

    MDR report key: 2925636 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00164
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K071082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER REJUVENATE HIP REPLACEMENT NECK. THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO PAIN INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. A REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE SUPER AND CHS COMPLAINT DATABASES SHOW THERE HAVE BEEN OTHER EVENTS FOR THE REPORTED LOT. SIMILAR EVENTS HAVE OCCURRED FOR THE CATALOG NUMBER AND PRODUCT FAMILY. THESE EVENTS WERE DETERMINED TO BE ASSOCIATED WITH RA 2012-067. 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 REVISION DUE TO PAIN IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT HAS INJURIES SUSTAINED AS A RESULT OF THE IMPLANTATION OF A STRYKER REJUVENATE HIP REPLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT SUSTAINED INJURIES AS A RESULT OF THE IMPLANTATION OF A STRYKER REJUVENATE HIP REPLACEMENT. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30342 LRG TAP PRI MOD NCK 0DEG 30MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 23282502

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R