BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY

    MDR report key: 9071804 · Received September 16, 2019

    Report

    Report Number
    0001825034-2019-04115
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    June 27, 2019
    Report Date
    September 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K113069
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI # (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 · 0

    IT WAS FURTHER REPORTED THROUGH PATIENT¿S MEDICAL RECORDS THAT PRIOR TO THE REVISION PROCEDURE, THE PATIENT UNDERWENT HOME THERAPY TO TRY AND RESOLVE THE REPORTED ADVERSE EVENTS. HOWEVER, THIS WAS UNSUCCESSFUL AND THEREFORE, THE REVISION PROCEDURE WAS PERFORMED. THE BEARING AND TRAY WERE REMOVED AND REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4), UDI #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMPREHENSIVE REVERSE SHOULDER BEARING CATALOG # EP115361 LOT # 429540. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER CATALOG # 010000589 LOT # 193550, COMP RVRS SHLDR GLNSP STD 41MM CATALOG # 115320 LOT # 352060 , COMP RVS CNTRL 6.5X45MM ST/RST CATALOG # 115399 LOT # 57347, COMP LK SCR 3.5HEX 4.75X35 ST CATALOG # 180554 LOT # 700070, COMP LK SCR 3.5HEX 4.75X35 ST CATALOG # 180554 LOT # 466990 , COMP LK SCR 3.5HEX 4.75X20 ST CATALOG # 180551 LOT # 993730, COMP LK SCR 3.5HEX 4.75X20 ST CATALOG # 180551 LOT # 807940 , COMP PRIMARY STEM 16MM MINI CATALOG # 113636 LOT # 882800. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-04116. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHT MONTHS POST-IMPLANTATION DUE TO INADEQUATE TENSION IN THE JOINT. PATIENT REPORTED DISSATISFACTION AND PAIN WITH RECURRENT EPISODES OF SUBLUXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867694 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY PROSTHESIS SHOULDER KWT ZIMMER BIOMET, INC. N/A 350670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R