BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 8478649 · Received April 3, 2019

    Report

    Report Number
    0001825034-2019-01504
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    November 27, 2017
    Report Date
    August 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060716
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS CONFIRMED WITH MEDICAL RECORDS RECEIVED. INITIAL LEFT SHOULDER SURGERY DUE TO GLENOHUMERAL ARTHRITIS. NO COMPLICATIONS/SIGNIFICANT FINDINGS NOTED. FOLLOW UP VISIT NOTED PAIN, WEAKNESS, LIMITED ROM, AND "POPPING AND CLICKING." X-RAY REVIEW NOTED "HEMI-ARTHROPLASTY THAT APPEARS PROUD WITH OVERSTUFFING." POST-REVISION NOTED PERIPROSTHETIC FRACTURE SUSTAINED AFTER A FALL. NO POST-REVISION ZB COMPLICATIONS NOTED DURING FOLLOW UP VISITS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113652, HUMERAL STEM, LOT 527180; 113044, HUMERAL HEAD, LOT 254680. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01503; 0001825034 - 2019 - 01505.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 5 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO ONGOING L SHOULDER PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270753 VERSA-DIAL/COMP TI STD TAPER PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 216550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R