BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL SCREW KIT 2 HUMERAL SCREWS

    MDR report key: 14220080 · Received April 27, 2022

    Report

    Report Number
    0001822565-2022-01208
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    December 9, 2020
    Report Date
    August 23, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    UDI-DI
    00889024271449
    PMA / PMN Number
    K123862
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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: 0001822565-2022-01206, 0001822565-2022-01209, 0001822565-2022-01210. MEDICAL PRODUCTS: ITEM#: 00840004410, HUMERAL COMPONENT PLASMA SPRAYED SIZE 4 100 MM LENGTH FOR CEMENTED USE ONLY; LOT#: 64264426. ITEM#: 00840001407, ULNAR COMPONENT PLASMA SPRAYED SIZE 4 75 MM LENGTH LEFT FOR CEMENTED USE ONLY; LOT#: 64122609. ITEM#: 00840009400, ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS B STERILE PRODUCT DO NOT RESTERILIZE; LOT#: 64067854. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2022-01206-1, 0001822565-2022-01209-1, 0001822565-2022-01210-1. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. 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 THE PATIENT HAD A NERVE INJURY THAT WAS PRE-EXISTING, BUT IT WORSENED AFTER THE INITIAL LEFT ELBOW PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A NERVE GRAFTING AND NERVE REPAIR SURGERY TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636498 HUMERAL SCREW KIT 2 HUMERAL SCREWS PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED JDC ZIMMER BIOMET, INC. N/A 64459992 00889024271449

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H SEE H10 NARRATIVE.