BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REUNION TSA - X3 PEGGED GLENOID - SIZE 52

    MDR report key: 3151522 · Received June 7, 2013

    Report

    Report Number
    0002249697-2013-01856
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HSD
    PMA / PMN Number
    K103835
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: CATALOG # PRODUCT DESCRIPTION LOT # 5552-S-5217, REUNION TSA - SR STANDARD HUMERAL HEAD 52X17, MKLH28. UNKNOWN, UNKNOWN STEM. UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING A REVISION DUE TO PAIN INVOLVING A REUNION TSA PEGGED GLENOID WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REMOVED REUNION TSA SHOULDER, ALL THREE UNITS BECAUSE PATIENT HAD PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REMOVED REUNION TSA SHOULDER, ALL THREE UNITS BECAUSE PATIENT HAD PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252197 REUNION TSA - X3 PEGGED GLENOID - SIZE 52 IMPLANT HSD STRYKER ORTHOPAEDICS-MAHWAH MLM4R1

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention