BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE MODULAR NEK 34MM V40

    MDR report key: 3600548 · Received January 13, 2014

    Report

    Report Number
    9616680-2014-00106
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    September 20, 2010
    Report Date
    December 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE HAVE BEEN SIMILAR EVENTS FOR THE REPORTED FAMILY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PT COMPLAINS OF PAIN AND DIFFICULTY WALKING SINCE SURGERY. A MICROSCOPIC SURGERY WAS PERFORM ON (B)(6) 2011, TO SEE WHEAT WAS CAUSING THE PROBLEM. PATIENT STATES THAT THEY REMOVED SOME TISSUE BUT NO IMPLANTS WERE REMOVED. SHE HAS HAD MRI AND BLOOD WORK. PATIENT HAS BEEN UNABLE TO GO BACK TO WORK SINCE HER SECOND MICROSCOPIC INTERVENTION. PT WILL BE HAVING A REVISION DUE TO THE CONTINOUS PAIN AND INABILITY TO BEAR WEIGHT ON THAT HIP. MRI AND BLOOD WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22854 REJUVENATE MODULAR NEK 34MM V40 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 32794601

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R