BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL REVERSE SHOULDER SYSTEM

    MDR report key: 5771594 · Received July 6, 2016

    Report

    Report Number
    5771594
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 24, 2016
    Report Date
    June 28, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT HAD LOCALIZED OSTEOARTHROSIS, PERSISTENT PAIN IN SHOULDER JOINT, BURSAE AND TENDONS IN THE WINTER OF LAST YR WITH SHOULDER ARTHROPLASTY REVERSE (RIGHT) LRB AT THAT TIME FINDINGS WERE DEFICIENT ROTATOR CUFF, POSTERIOR INSTABILITY. IMPLANT AT THAT TIME WAS ZIMMER INSERT HUMERAL REV TM 7D40X=6MM. MIDDLE OF THE LAST MONTH, THE PATIENT EXPERIENCED PERSISTENT RIGHT SHOULDER PAIN AND XRAYS CONFIRMED A DISLOCATION OF HIS REVERSE PROSTHESIS AND SCHEDULED A RIGHT SHOULDER REVISION PROSTHESIS. THE POLY COMPONENT WAS NOTED TO BE LOOSE SITTING WITHIN THE STEM AND HAD A LARGE DIVOT OF DEFECT WITHIN IT; REMOVED AND RESIDUAL REMAINING HUMERAL STEM WAS EVALUATED AND FELT TO BE STABLE, NO ROTATIONAL INSTABILITY NOTED. A 9 MM SPACER WAS SUBSEQUENTLY PLACED ONTO THE NATIVE HUMERAL STEM. VARIOUS SIZED POLYS WERE ATTEMPTED AND ULTIMATELY A 6 MM RETRATINED LINER WAS CHOSEN AND SUBSEQUENTLY REDUCED; FELT TO BE ADEQUATELY STABLE IN ALL PLANED WITH FAIRLY FLACID DELTOID BUT IT WAS FELT THAT FURTHER LENGTHENING WOULD NOT HELP WITH THE DELTOID. PATIENT STABLE AND TAKEN TO POSTANESTHESIA RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428142 TRABECULAR METAL REVERSE SHOULDER SYSTEM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD ZIMMER, INC. TM 7D40X+6MM

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR