BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9

    MDR report key: 2904440 · Received January 9, 2013

    Report

    Report Number
    0002249697-2013-00013
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). 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 (B)(4). VOLUNTARY RECALL RA (B)(4) WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED ALTRIS 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 RETAINED BY THE PATIENT AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD PROGRESSIVE PAIN RIGHT HIP. AT SURGERY: WATERY FLUID, THICK CREAM COLORED PSEUDO TUMOR, SOME CORROSION SEEN AT NECK BODY JUNCTION (MODULAR NECK TO STEM.) STEM WELL FIXED IN BONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD PROGRESSIVE PAIN RIGHT HIP. AT SURGERY: WATERY FLUID, THICK CREAM COLORED PSEUDO TUMOR, SOME CORROSION SEEN AT NECK BODY JUNCTION (MODULAR NECK TO STEM.) STEM WELL FIXED IN BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12647 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MJK266

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR