BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISC CONDYLE KIT W/ HEXALOBULA

    MDR report key: 8770961 · Received July 9, 2019

    Report

    Report Number
    0001825034-2019-02660
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    May 12, 2016
    Report Date
    August 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    K051975
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT ZIMMERBIOMET DOES NOT HOLD REPORTING RESPONSIBILITY FOR THE REPORTED DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT ZIMMERBIOMET DOES NOT HOLD REPORTING RESPONSIBILITY FOR THE REPORTED DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 114816, LOT# 265200, DISC ULNA 3X115MM LT W/BRNG C. ITEM# 114918, LOT# 310670, DISC HUM 6X150MM LT FLANGED C. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02659, 0001825034-2019-02661. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL ELBOW ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DAMAGED HUMERAL CONDYLE KIT AND BEARINGS, AND SEVERE CATASTROPHIC WEAR OF THE ULNAR COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565516 DISC CONDYLE KIT W/ HEXALOBULA EXTREMITIES, IMPLANT JDC ZIMMER BIOMET, INC. N/A 385190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention