BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID GLENOID BASE SMALL

    MDR report key: 7251243 · Received February 8, 2018

    Report

    Report Number
    0001825034-2018-00560
    Event Type
    Injury
    Date Received
    February 8, 2018
    Report Date
    February 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: COMPREHENSIVE SHOULDER PRIMARY MINI LENGTH SHOULDER STEM, PN: 113629, LN: 253120; VERSA-DIAL SHOULDER MODULAR HEAD W/ VARIABLE OFFSET, PN: 113022, LN: 152090; VERSA-DIAL SHOULDER COMPREHENSIVE STANDARD ADAPTOR, PN: 118001, LN: 811860; PT HYBRID GLENOID POST REGENEREX ,PN: PT-113950, LN: 431990. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00558, 0001825034-2018-00559, 0001825034-2018-00561 AND 0001825034-2018-00562. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS BEEN INDICATED FOR REVISION WITH A CUSTOM DEVICE DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100072 HYBRID GLENOID BASE SMALL PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 555500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention