BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9

    MDR report key: 2930028 · Received January 25, 2013

    Report

    Report Number
    0002249697-2013-00286
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    October 23, 2012
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING EXCESSIVE METAL IONS INVOLVING A REJUVENATE MODULAR DEVICE WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO DEVICES WERE RECEIVED. A 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 EXCESSIVE METAL IONS IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    LABS TAKEN ON (B)(6) 2012 INDICATE ELEVATED COBALT (11 NG/ML) AND CHROMIUM (1.2 NG/ML) ION LEVELS; NO FURTHER INFORMATION AVAILABLE IN CLINIC OR HOSPITAL RECORDS. THE PATIENT IS DUE FOR A 2-YEAR FOLLOW-UP VISIT IN (B)(6) 2013.

    Description of Event or Problem · 1

    LABS TAKEN ON (B)(6) 2012 INDICATE ELEVATED COBALT (11 NG/ML) AND CHROMIUM (1.2 NG/ML) ION LEVELS; NO FURTHER INFORMATION AVAILABLE IN CLINIC OR HOSPITAL RECORDS. THE PATIENT IS DUE FOR A 2-YEAR FOLLOW-UP VISIT IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35980 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MJA7X6

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other