BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2936151 · Received January 30, 2013

    Report

    Report Number
    0002249697-2013-00493
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    July 1, 2012
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES REMAIN IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. CATALOGUE NUMBER IS UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN REJUVENATE MODULAR NECK. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. THE PATIENT IS (B)(6). AN EVENT REGARDING REVISION DUE TO PAIN INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THE COMPLAINT DATABASES SHOW THERE HAVE NOT 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. CONCLUSIONS: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PATIENT IS EXPERIENCING PAIN AND PROBLEMS WITH IMPLANT SINCE SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN IN THE LEG AND GROIN SO THE SURGEON REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41203 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH KJ9MTD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention