BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 38MM

    MDR report key: 2931292 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00348
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 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 DUE TO HOSPITAL POLICY. 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

    THE PATIENT IS(B)(6) IN HEIGHT. AN EVENT REGARDING REVISION DUE TO EXCESSIVE METAL IONS 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 SUPER AND CHS 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 REVISION DUE TO EXCESSIVE METAL IONS IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENTS LEFT REJUVENATE HIP WAS REVISED. PATIENT WAS REVISED DUE TO ELEVATED COBALT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENTS LEFT REJUVENATE HIP WAS REVISED. PATIENT WAS REVISED DUE TO ELEVATED COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37284 LRG TAP PRI MOD NCK 0DEG 38MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 32356601

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention