BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASE PLATE 15 MM POST LENGTH UNCEMENTED

    MDR report key: 12348624 · Received August 20, 2021

    Report

    Report Number
    0001822565-2021-02313
    Event Type
    Injury
    Date Received
    August 20, 2021
    Date of Event
    July 16, 2021
    Report Date
    September 22, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    K121543
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). CONCOMITANT MEDICAL PRODUCTS: INVERS/REVERS SCR SYST 4.5-36, CAT: 01.04223.036, LOT: 3046210. INVERS/REVERS SCR SYST 4.5-30, CAT: 01.04223.030, LOT: 3021340. GLENOSPHERE 36 MM DIAMETER, CAT: 00434903611, LOT: 64844939. REPORT SOURCE: FOREIGN: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 1 WEEK POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO LOOSENING OF THE BASEPLATE. THERE WERE NO REPORTED CONTRIBUTING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247341 BASE PLATE 15 MM POST LENGTH UNCEMENTED SHOULDER, PROSTHESIS HSD ZIMMER BIOMET, INC. 64688111

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R