BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER

    MDR report key: 6510694 · Received April 21, 2017

    Report

    Report Number
    0001825034-2017-02693
    Event Type
    Injury
    Date Received
    April 21, 2017
    Report Date
    May 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY FOUND NO OTHER COMPLAINTS OF THIS NATURE FOR THE REPORTED PART/LOT COMBINATION, AND DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: CATALOG #: 110004347, SIG GLEN CT GD/BONE MODEL SET, LOT # 669660. CATALOG #: 113630, COMP PRIMARY STEM 10MM MINI, LOT # 752210. CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 030580. CATALOG #: 115370, COMP RVS TRAY CO 44MM, LOT # 731050. CATALOG #: 115394, COMP RVS CNTRL 6.5X20MM ST/RST, LOT # 057050. CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 118100. CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 070930. CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 015350. CATALOG #: 20800000011, CAS FIXATION PIN 3.2D X 80MM STERILE, LOT # 63298687. CATALOG #: 20800000011, CAS FIXATION PIN 3.2D X 80MM STERILE, LOT # 63449453. CATALOG #: EP-115393, E1 44-36 STD HMRL BRNG, LOT # 884260. CUSTOMER HAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY REVISION APPROXIMATELY SIX (6) WEEKS POST-OPERATIVELY DUE TO THE GLENOSPHERE DISASSOCIATING FROM THE MINI BASEPLATE. THE HUMERAL TRAY, BEARING, GLENOSPHERE, AND BASEPLATE WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294000 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 576800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE