BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2931288 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00349
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    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. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    UPDATED EXPLANT DATE BASED ON ADDITIONAL INFORMATION. AN EVENT REGARDING ALTR INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOUND THE DEVICES IN THE REPORTED LOT WERE ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. 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. 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 ALTR IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ACCORDING TO DR. (B)(6). PATIENT SHOWED SYMPTOMS OF METAL SENSITIVITY, AND PSEUDO TUMOR. POSITIVE MARS SCAN. ELEVATED SERUM COBALT AND CHROME LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ACCORDING TO DR. (B)(6). PATIENT SHOWED SYMPTOMS OF METAL SENSITIVITY, AND PSEUDO TUMOR. POSITIVE MARS SCAN. ELEVATED SERUM COBALT AND CHROME LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37455 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MKR6H8

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention