BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP AUG MINI BSPLT W TPR MD

    MDR report key: 12134277 · Received July 8, 2021

    Report

    Report Number
    0001825034-2021-01996
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    April 2, 2021
    Report Date
    September 7, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304993242
    PMA / PMN Number
    K172502
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01243-1 0001825034-2021-01244-1 0001825034-2021-01245-1 0001825034-2021-01246-1 THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; G3; G6; H1; H2; H6 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-01243, 0001825034-2021-01244, 0001825034-2021-01245, 0001825034-2021-01246. MEDICAL PRODUCTS: ITEM#: 115396, COMP RVS CNTRL 6.5X30MM ST/RST; LOT#: 071250; ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 568750; ITEM#: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST; LOT#: 109940; ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 553500; ITEM#: 113057, VERSA-DIAL 50X27X50 HUM HEAD; LOT#: 886670; ITEM#: 118001, VERSA-DIAL/COMP TI STD TAPER; LOT#: 277440; ITEM#: 113630, COMP PRIMARY STEM 10MM MINI; LOT#: 64548820. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT WAS DISCARDED BY HOSPITAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT SHOULDER REVISION SURGERY APPROXIMATELY THREE (3) WEEKS AGO WHILE DURING A REVISION SURGERY FOR UNKNOWN REASON SURGEON WAS TRIALING THE BASE PLATE CAME OUT ALONG WITH GLENOSPHERE. IT WAS REPORTED BY THE SURGEON THAT THE PATIENT'S BONE WAS SOFT AND THAT THE REVISION WAS THEN CONVERTED TO A HEMIARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036511 COMP AUG MINI BSPLT W TPR MD SHOULDER/PROSTHESIS KWS ZIMMER BIOMET, INC. N/A 64180837 00880304993242

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R