BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2925367 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00145
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    August 9, 2011
    Report Date
    January 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED UNKNOWN STRYKER REJUVENATE HIP REPLACEMENT STEM.THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION 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 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 IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    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

    ADDITIONAL INFORMATION RECEIVED ON 06/24/2014 : IT WAS REPORTED THAT THE PATIENT HAD A LEFT HIP REVISION SURGERY ON (B)(6) 2013."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30640 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH MJR1WV

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention