BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X40 ST

    MDR report key: 17031056 · Received May 31, 2023

    Report

    Report Number
    0001825034-2023-01227
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    April 22, 2023
    Report Date
    August 29, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677180
    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

    CMP-0876927 THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL/CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-01228-1, 0001825034-2023-01627, 0001825034-2023-01628, 0001825034-2023-01631. D10: MEDICAL PRODUCTS: ITEM#: 180556, COMP LK SCR 3.5HEX 4.75X45 ST; LOT#: 942790, ITEM#: 180556, COMP LK SCR 3.5HEX 4.75X45 ST; LOT#: 922110, ITEM#: 180555, COMP LK SCR 3.5HEX 4.75X40 ST; LOT#: 962390, ITEM#: 115400, COMP RVS CNTRL 6.5X50MM ST/RST; LOT#: 343310. H3: 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.

    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: 0001825034-2023-01228-2. 0001825034-2023-01627-1. 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. 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: 0001825034-2023-01228. D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN SCREW; LOT#: UNKNOWN. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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 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.

    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 REVISION SURGERY DUE TO THE IMPLANT FRACTURING. THIS IS THE PATIENT'S THIRD REVISION SURGERY AND THE SECOND TIME THE PATIENT HAS BEEN REVISED DUE TO AN IMPLANT FRACTURING. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO RESPONSE HAS BEEN MADE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296724 COMP LK SCR 3.5HEX 4.75X40 ST SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 180555 867190 00880304677180
    1704259 COMP LK SCR 3.5HEX 4.75X40 ST SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES PHX ZIMMER BIOMET, INC. 180555 867190 00880304677180

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| L