BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X25 ST

    MDR report key: 15445752 · Received September 19, 2022

    Report

    Report Number
    0001825034-2022-02128
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    August 23, 2022
    Report Date
    January 12, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677159
    PMA / PMN Number
    K130390
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-02126, 0001825034-2022-02127. DEVICE PRODUCT CODE: PHX. PRODUCT ID WAS PROVIDED FOR TWO HEX SCREWS; HOWEVER, IT IS UNKNOWN WHICH ONE OF THE TWO HEX SCREWS FRACTURED. THEREFORE, THE OTHER POSSIBLE ITEM AND LOT NUMBERS FOR THIS EVENT ARE: ITEM# 180552; LOT# 905490, UDI: (B)(4), STERILE DATE: MAY 19, 2031. CONCOMITANT MEDICAL PRODUCTS: ITEM# 115330; LOT# 185040; ITEM# 115396; LOT# 905900; ITEM# 180552; LOT# 905490; ITEM# 110030777; LOT#11024237; ITEM#110031400; LOT# 65095786; ITEM# 110031421; LOT# 64343831; ITEM#118001; LOT# J7192948; ITEM#113077; LOT# 314170. 510K NUMBER FOR ITEM# 180552; LOT# 905490 - K130390. MANUFACTURING DATE FOR ITEM# 180552; LOT# 905490 - MAY 19, 2021. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PHOTOGRAPHS IDENTIFIED THE IMPLANTS THAT WERE EXPLANTED. A CENTRAL SCREW AND PERIPHERAL SCREW APPEAR BROKEN. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SIGNIFICANT FINDINGS INCLUDE A FRACTURED CENTRAL SCREW OF THE GLENOID COMPONENT IS IDENTIFIED. NO CONTRIBUTE FACTORS ARE SEEN. 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 WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS REVISED APPROXIMATELY ONE (1) YEAR AND TWO (2) MONTHS POST-IMPLANTATION DUE TO NO FIXATION OF THE BASEPLATE AND TWO (2) FRACTURED SCREWS. DURING THE PROCEDURE, THE BASEPLATE, GLENOSPHERE, POLY AND SCREWS WERE REMOVED AND PATIENT WAS CONVERTED TO A HEMI SHOULDER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371555 COMP LK SCR 3.5HEX 4.75X25 ST SHOULDER PROSTHESIS, REVERSE CONFIGURATION KWS ZIMMER BIOMET, INC. NI 763020 00880304677159

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE NARRATIVE H10.