BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE VERSA-DIAL 50X24X52 HUMERAL HEAD

    MDR report key: 7981713 · Received October 18, 2018

    Report

    Report Number
    0001825034-2018-09081
    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
    HSD
    PMA / PMN Number
    PK060716
    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 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: 283780M 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
    822957 COMPREHENSIVE VERSA-DIAL 50X24X52 HUMERAL HEAD PROSTHESIS, EXTREMITY HSD ZIMMER BIOMET, INC. N/A 792010

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other