BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE® REVERSE SHOULDER CENTRAL SCREW

    MDR report key: 20515487 · Received October 23, 2024

    Report

    Report Number
    0001825034-2024-02491
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    September 26, 2024
    Report Date
    January 24, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304677098
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 180554 (835070); 180554 (835070); 180553(161210); 108553 (160810). ASSOCIATED PRODUCT INFORMATION: 110027734 (182270); 115313 (J7177943); 118000 (J7210693); 110031424 (65163892); 110031402 (65255208). THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION PER 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 THAT 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 HAS BEEN CONFIRMED THROUGH THE PROVIDED PHOTO. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED EXPLANTED DEVICES WITH BIO DEBRIS STILL ON THEM. SCREW FRACTURE IS ABLE TO BE SEEN ON MULTIPLE SCREWS. HOWEVER, AS PRODUCTS DID NOT RETURN, FURTHER ANALYSIS COULD NOT BE PERFORMED. A 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF YEARS (2.5) YEARS FOLLOWING SHOULDER ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION DUE TO FRACTURED BASEPLATE SCREWS. THE BASEPLATE, GLENOSPHERE, TRAY, BEARING, AND SCREWS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS. THE CASE WAS COMPLETED WITHOUT ANY REPORTED ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    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
    294620 COMPREHENSIVE® REVERSE SHOULDER CENTRAL SCREW SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 100860 00880304677098

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H H11.