BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 8674670 · Received June 6, 2019

    Report

    Report Number
    0001825034-2019-02449
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    May 21, 2019
    Report Date
    November 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : ITEM# 115395; COMP RVS CNTRL 6.5X25MM ST/RST; LOT# 522910, ITEM# 115313; COMP RVSR SHLDR GLNSP +3 36MM; LOT# 020060, ITEM# 180553; COMP LK SCR 3.5HEX 4.75X30 ST; LOT# 602720, ITEM# 180553; COMP LK SCR 3.5HEX 4.75X30 ST; LOT# 042760, ITEM# 180554; COMP LK SCR 3.5HEX 4.75X35 ST; LOT# 878350, ITEM# 113613; COMP PRIMARY STEM 13MM MICRO; LOT# 904750, ITEM# 115378; COMP RVS TRAY +10MM CO 44MM; LOT# 800040, ITEM# XL-115364; ARCOM XL 44-36 STD +3 HMRL BRG; LOT# 247330. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04938, 0001825034-2019-04940, 0001825034-2019-04941, 0001825034-2019-04942, 0001825034-2019-04943, 0001825034-2019-04944, 0001825034-2019-04945, 0001825034-2019-04946.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHT MONTHS POST INITIAL DUE TO INFECTION. A SPACER MOLD WAS TEMPORARILY IMPLANTED AND REMOVED AT A LATER DATE. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: FOREIGN (B)(6). THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS SCHEDULED FOR A REVISION SURGERY TO REPLACE THE GLENOID BASEPLATE FOR BONE LOSS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470205 COMP RVRS 25MM BSPLT HA+ADPTR EXTREMITIES, IMPLANT KWS ZIMMER BIOMET, INC. N/A 296770

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R