BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE BASE PLATE HA+ ADAPTOR

    MDR report key: 7374493 · Received March 27, 2018

    Report

    Report Number
    0001825034-2018-02232
    Event Type
    Injury
    Date Received
    March 27, 2018
    Report Date
    March 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS- COMP VRSDL GLNSPR 36MM +6 TI # ITEM TI-115316 LOT 580240, COMP PRIMARY STEM 9MM STD # ITEM 113649 LOT 462080, ARCOM XL 44-36 STD HMRL BRNG # ITEM XL-115363 LOT 306010, COMP RVS HMRL TI TRAY 44MM # ITEM 115340 LOT 587760, COMP RVS CNTRL 6.5X20MM ST/RST # ITEM 115394 LOT 991050, COMP LK SCR 3.5HEX 4.75X20 ST # ITEM 180551 LOT 151260, COMP LK SCR 3.5HEX 4.75X30 ST # ITEM 180553 LOT 211380, COMP LK SCR 3.5HEX 4.75X35 ST # ITEM 180554 LOT 278260. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A GLENOID FRACTURE AND POSSIBLE BASEPLATE MIGRATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISED DUE TO A GLENOID FRACTURE AND POSSIBLE BASEPLATE MIGRATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217323 COMPREHENSIVE REVERSE BASE PLATE HA+ ADAPTOR PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 801620

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R