BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2911724 · Received January 11, 2013

    Report

    Report Number
    0002249697-2013-00024
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    August 23, 2011
    Report Date
    November 8, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO ELEVATED COBALT/CHROME INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: 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. 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 ELEVATED COBALT/CHROME IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTS PATIENT IS EXPERIENCING SYMPTOMS RELATED TO ELEVATED COBALT/CHROME, INCLUDING PSEUDOTUMOR. POSITIVE MARS SCAN.

    Description of Event or Problem · 1

    DR. (B)(6). REPORTS PATIENT IS EXPERIENCING SYMPTOMS RELATED TO ELEVATED COBALT/CHROME, INCLUDING PSEUDOTUMOR. POSITIVE MARS SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18462 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH MKH8YE

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention