BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MD HYBRID GLENOID BASE 4MM

    MDR report key: 6909176 · Received October 2, 2017

    Report

    Report Number
    0001825034-2017-07689
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    June 15, 2017
    Report Date
    March 12, 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 · 1

    (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 MDR WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 118001, VERSA-DIAL/COMP TI STD TAPER, 016610; 113055, VERSA-DIAL 50X24X52 HUM HEAD, 792010; 113633, COMP PRIMARY STEM 13MM MINI, 283780; PT-113950, PT HYBRID GLEN POST REGENEREX, 865440. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07688.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY PROCEDURE DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, THE PATIENT EXPERIENCED WORSENING SUBLUXATION FOLLOWING A PECTORALIS TENDON TRANSFER PROCEDURE. IT IS ALSO REPORTED THAT THE PATIENT HAS PAIN ON BOTH THE ANTERIOR - SUPERIOR AND ANTERIOR - LATERAL SIDES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688496 MD HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 095580

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other