BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 17108220 · Received June 12, 2023

    Report

    Report Number
    0001825034-2023-01301
    Event Type
    Injury
    Date Received
    June 12, 2023
    Date of Event
    May 11, 2023
    Report Date
    November 29, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304532465
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS REPORTED THAT A PATIENT FELL CAUSING DISASSOCIATION BETWEEN THE TAPER ADAPTER AND THE BASEPLATE. AFTER THE FALL AND BEFORE THE REVISION OCCURRED, THE BASEPLATE WAS WEARING ON THE POLY WHICH CAUSED AN ABNORMAL WEAR PATTERN. THE BASEPLATE WORE DOWN TO THE HUMERAL TRAY LEADING TO METAL ON METAL WEAR. DEBRIS OF THE METAL ON METAL WEAR IS PRESENT ON THE POLY. THE COMPLICATIONS WERE INDICATED AS BEING THE RESULT OF THE FALL WITH NO CONCERNS OR ALLEGATIONS PRIOR. AS THIS IS AN UPPER EXTREMITY IMPLANT, IT WOULD NOT HAVE CAUSED/CONTRIBUTED TO THE FALL AND SUBSEQUENT COMPLICATIONS.

    Additional Manufacturer Narrative · 0

    (B)(4). BEARING +3 MM RETENTIVE THICKNESS 36 MM DIAMETER CAT: 110031426 LOT: 64465284. COMP LK SCR 3.5HEX 4.75X30 ST CAT: 180553 LOT: 791810. COMP RVRS SHLDR GLNSP STD 36MM CAT: 115310 LOT: 662660. COMP RVRS 25MM BSPLT HA+ADPTR CAT: 010000589 LOT: 564600. COMP RVS CNTRL 6.5X30MM ST/RST CAT: 115396 LOT: 100840. COMP LK SCR 3.5HEX 4.75X25 ST CAT: 180552 LOT: 792150. COMP PRIMARY STEM 9MM MINI CAT: 113629 LOT: 170250. BEARING STANDARD 36 MM DIAMETER CAT: 110031424 LOT: 64510457. MINI TRAY STD COCR +3 OFFSET CAT: 110031402 LOT: 64512179. 25MM VERSA-DIAL TAPER ADAPTOR CAT: 118000 LOT: 741600. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01300, 0001822565-2023-01534. 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELL AND THE GLENOSPHERE WAS DISLOCATED. THE BEARING WAS FOUND TO BE WORN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367385 COMP RVRS 25MM BSPLT HA+ADPTR SHOULDER, PROSTHESIS KWS ZIMMER BIOMET, INC. 010000589 564600 00880304532465

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10