BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE MD HYBRID GLENOID BASE 4MM

    MDR report key: 7981718 · Received October 18, 2018

    Report

    Report Number
    0001825034-2018-09078
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    May 8, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 TREND.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113633, LOT: 283780 COMPREHENSIVE MINI STEM; 118001, LOT: 016610 VERSA-DIAL TAPER ADAPTER; 113055, LOT: 792010 COMPREHENSIVE VERSA-DIAL HUMERAL HEAD; 113954, LOT: 095580 MEDIUM BIOMET HYBRID GLENOID BASE; PT-113950, LOT: 865440 BIOMET HYBRID GLENOID POST WITH REGENEREX. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED LEFT SHOULDER INSTABILITY TWO YEARS POST PRIMARY IMPLANTATION. IMPINGEMENT AND PAIN WERE ALSO NOTED AT THE TWO YEAR FOLLOW-UP VISIT. NO REVISION HAS BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822960 COMPREHENSIVE MD HYBRID GLENOID BASE 4MM PROSTHESIS, EXTREMITY KWS ZIMMER BIOMET, INC. N/A 095580

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other