BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE MINI HUMERAL STEM

    MDR report key: 7981484 · Received October 18, 2018

    Report

    Report Number
    0001825034-2018-09082
    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
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 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
    817349 COMPREHENSIVE MINI HUMERAL STEM PROSTHESIS, EXTREMITY KWS ZIMMER BIOMET, INC. N/A 283780

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other