BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2911739 · Received January 11, 2013

    Report

    Report Number
    0002249697-2013-00027
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    February 23, 2012
    Report Date
    November 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DEVICE EVALUATED BY MFR: NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO ELEVATED COBALT/CHROME INVOLVING AN UNKNOWN REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. REVIEW OF DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT PROPERLY IDENTIFIED. SIMILAR EVENTS HAVE OCCURRED FOR THE REJUVENATE MODULAR 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

    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
    18467 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention