BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X45 ST

    MDR report key: 17324350 · Received July 14, 2023

    Report

    Report Number
    0001825034-2023-01627
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    April 22, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677197
    PMA / PMN Number
    K130390
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01227-2, 0001825034-2023-01228-2, 0001825034-2023-01628-1, 0001825034-2023-01631-1. 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. THE REPORTED EVENT WAS CONFIRMED VIA PROVIDED RADIOGRAPHS. NO DEVICES WERE RETURNED FOR EXAMINATION. UPON HCP REVIEW OF THE PROVIDED RADIOGRAPHS, IT WAS IDENTIFIED THAT THERE WERE MULTIPLE GLENOID IMPLANT SCREWS FRACTURED, WITH POSSIBLY ONE SCREW INTACT SUPERIORLY. THE GLENOID IMPLANT IS DISPLACED FROM THE GLENOID. THERE IS NOT DISLOCATION SEEN. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01227-1; 0001825034-2023-01228-1; 0001825034-2023-01628; 0001825034-2023-01631. MEDICAL PRODUCTS: ITEM#: 180555, COMP LK SCR 3.5HEX 4.75X40 ST; LOT#: 867190; ITEM#: 180556, COMP LK SCR 3.5HEX 4.75X45 ST; LOT#: 942790; ITEM#: 180555, COMP LK SCR 3.5HEX 4.75X40 ST; LOT#: 962390; ITEM#: 115400, COMP RVS CNTRL 6.5X50MM ST/RST; LOT#: 343310. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WERE NOT RETURNED BY THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND STAGE REVISION PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FRACTURED SCREWS APPROXIMATELY FOUR (4) MONTHS POST-IMPLANTATION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT UNDERWENT A REVISION SURGERY OVER A YEAR AND A HALF AGO DUE TO FRACTURED SCREWS. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO FRACTURED VRS SCREWS. PATIENT WAS IMPLANTED WITH A SHOULDER HEMI. THIS IS THE THIRD REVISION SURGERY AND SECOND SURGERY DUE TO FRACTURING OF IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207756 COMP LK SCR 3.5HEX 4.75X45 ST SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 180556 922110 00880304677197

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R