BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY SMALL LEFT

    MDR report key: 18236508 · Received November 30, 2023

    Report

    Report Number
    0001822565-2023-03395
    Event Type
    Injury
    Date Received
    November 30, 2023
    Date of Event
    July 14, 2022
    Report Date
    November 29, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    K181307
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-02311-2. D10: MEDICAL PRODUCTS: ITEM#: 32810502504, INTERCHANGEABLE HUMERAL ASSEMBLY FOR CEMENTED USE ONLY SMALL; LOT#: 62738583. ITEM#: 32810505301, INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY SMALL LEFT; LOT#: 62733349. ITEM#: 32810502501; PIN/BUSHING REPLACEMENT KIT SMALL/REGULAR; LOT#: 64223127. G2: FOREIGN: NEW ZEALAND. VISUAL EXAMINATION OF THE RETURNED PRODUCT SHOWED WEAR AND TEAR. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. X-RAYS WERE INITIALLY PROVIDED; HOWEVER, THEY WERE NOT SENT FOR REVIEW AS THE DATES THEY WERE TAKEN ARE UNKNOWN AND WEAR WOULD BE DIFFICULT TO IDENTIFY IN THE CURRENT IMAGES. OP NOTES WERE NOT PROVIDED. IT REMAINS THAT A DEFINITIVE ROOT CAUSE CANNOT 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 · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT ELBOW REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO BEARING WEAR. THE HUMERAL BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071781 INTERCHANGEABLE ULNAR ASSEMBLY FOR CEMENTED USE ONLY SMALL LEFT PROTHESIS, ELBOW, CONSTRAINED, CEMENTED/EXTREMITIES JDC ZIMMER BIOMET, INC. 62733349

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| R SEE H10 NARRATIVE