BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR CENTER POST REAMER

    MDR report key: 16706843 · Received April 10, 2023

    Report

    Report Number
    0001822565-2023-00895
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 15, 2023
    Report Date
    July 6, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00889024574779
    PMA / PMN Number
    K191814
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. ASSOCIATED PRODUCTS AND REPORTS 0001822565-2023-00896, ITEM#SBGL3007; LOT#64808624. OTHER ASSOCIATED PRODUCTS ITEM#405800; LOT#65795032, IITEM#SAGL2042; LOT#65877236, ITEM#SAGP0002; LOT#65455457, ITEM#113630; LOT#65576403, ITEM#113032; LOT#J7316867, ITEM#118001; LOT#J7347730.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED CODE: MECHANICAL (G04) - DRILL. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED WEAR AROUND THE COLLAR AND HAD CRACKED AND DAMAGED TIPS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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 A REAMER BROKE DURING A PROCEDURE. NO HARM OR IMPACT TO THE PATIENT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS AVAILABLE AT THIS TIME.

    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
    1795321 MODULAR CENTER POST REAMER PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ZIMMER BIOMET, INC. NI 64808624 00889024574779

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female SEE NARRATIVE IN H10.