BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X20 ST

    MDR report key: 16952945 · Received May 18, 2023

    Report

    Report Number
    0001825034-2023-01096
    Event Type
    Injury
    Date Received
    May 18, 2023
    Date of Event
    May 3, 2023
    Report Date
    August 24, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677142
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: UNKNOWN BASEPLATE CAT: 115396 LOT: 783340 COMP RVS CNTRL 6.5X30MM ST/RST. CAT: 180553 LOT: 243940 COMP LK SCR 3.5HEX 4.75X30 ST. CAT: 180554 LOT: 227220 COMP LK SCR 3.5HEX 4.75X35 ST. CAT: 180552 LOT: 050600 COMP LK SCR 3.5HEX 4.75X25 ST. CAT: 180553 LOT: 530830 COMP LK SCR 3.5HEX 4.75X30 ST. UNKNOWN GLENOSPHERE. UNKNOWN HUMERAL STEM. CAT: XL-115363 LOT: 792370 ARCOM XL 44-36 STD HMRL BRNG. CAT: XL-115364 LOT: 875560 ARCOM XL 44-36 STD +3 HMRL BRG. CAT: 115370 LOT: UNKNOWN COMP RVS TRAY CO 44MM. G2: FOREIGN- UNITED KINGDOM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 -  2023 -  01091, 0001825034 -    2023 -  01092, 0001825034 -    2023 -  01093, 0001825034 -  2023 -  01094, 0001825034 -    2023 -  01095, 0001825034 -  2023 -  01097.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D2, G3, G6, H1, H2, H3, H6, H10 REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THAT THE CENTRAL SCREW AND ONE OTHER SCREW WERE BROKEN. THE IMAGES ARE NOT CLEAR ENOUGH TO DETERMINE IF THE OTHER SCREWS ARE ALSO BROKEN. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 UNDERWENT A REVISION PROCEDURE APPROXIMATELY NINETEEN MONTHS POST INITIAL PROCEDURE DUE TO FRACTURED SCREWS AND LOOSENING OF BASEPLATE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995672 COMP LK SCR 3.5HEX 4.75X20 ST PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. 180551 276310 00880304677142

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H