BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 17258690 · Received July 5, 2023

    Report

    Report Number
    0001825034-2023-01518
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    June 6, 2023
    Report Date
    October 23, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2023 -01516. D10: UNKNOWN GLENOSPHERE TAPER ADAPTOR. COMP LK SCR 3.5HEX 4.75X35 ST CAT: 180554 LOT: 820860. COMP RVS CNTRL 6.5X40MM ST/RST CAT: 115398 LOT: 920060. COMP LK SCR 3.5HEX 4.75X20 ST CAT: 180551 LOT: 053580. COMP LK SCR 3.5HEX 4.75X20 ST CAT: 180551 LOT: 65930432. COMP LK SCR 3.5HEX 4.75X35 ST CAT: 180554 LOT: 100220. COMP RVSR SHLDR GLNSP +3 36MM CAT: 115313 LOT: J7152564. HMRL TRAY STD +5 CAT: 110031400 LOT: 65754318. HMRL BEARING 36 MM STD VITE CAT: 110031424 LOT: 65761125. COMP RVRS SHDR GLEN 28MM BSPLT +HA CAT: 115330 LOT: 012970. VERSA-DIAL/COMP TI STD TAPER CAT: 118001 LOT: J7332185. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED THE DEVICE WAS RETURNED STILL ATTACHED TO THE TAPER ADAPTOR AND WAS SEPARATED TO REVEAL THE LOT NUMBER INFORMATION. THERE ARE SCRATCHES ON BOTH THE TAPER ADAPTOR AND THE BASEPLATE. THE GLENOSPHERE HAS A FEW MINOR SCUFFS/SCRAPES AS WELL. THERE IS ALSO SOME BIO DEBRIS ON THE BASEPLATE AS WELL. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE REPORTED EVENT NOT CONFIRMED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 REPORTED THAT THE PATIENT WAS REVISED DUE TO GLENOSPHERE TAPER DISASSOCIATED FROM THE BASEPLATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775269 COMP RVRS 25MM BSPLT HA+ADPTR SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. 010000589 498070

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10.