BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2933199 · Received January 29, 2013

    Report

    Report Number
    0002249697-2013-00397
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS UNKNOWN REJUVENATE/ABG II STEM. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. A 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 REVISION DUE TO ADVERSE LOCAL TISSUE REACTION (ALTR) IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL. NO FURTHER INVESTIGATION IS REQUIRED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND RESTRICTED MOVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND RESTRICTED MOVEMENT. UPDATE: IT WAS REPORTED THAT, MECHANICALLY ASSISTED CREVICE CORROSION AND SECONDARY ADVERSE LOCAL SOFT TISSUE REACTION AND PSEUDOTUMOR FORMATION AFTER REJUVENATE FEMORAL COMPONENT DUE TO MODULAR NECK-STEM MECHANISM OF FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38618 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MKMP0X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R