BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISC ULNA 5X75MM LT W/BRNG C

    MDR report key: 11854663 · Received May 20, 2021

    Report

    Report Number
    0001825034-2021-01317
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 26, 2021
    Report Date
    July 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    K043505
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE BEARING AS BEING WORN. DEVICE NOT RETURNED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: ITEM# 211250; LOT# 142530; COMP SRS DISC 50MM DST BDY LT; ITEM# 114700; LOT# 643330; DISC CONDYLE KIT W/ HEXALOBULA; ITEM# 211269; LOT# 666460; COMPR SRS SMALL FLANGE. FOREIGN: EVENT OCCURRED IN (B)(6). 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO BEARING WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756904 DISC ULNA 5X75MM LT W/BRNG C EXTREMITIES,IMPLANTS JDC ZIMMER BIOMET, INC. N/A 390880

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R