BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER NEXEL TOTAL ELBOW HUMERAL COMPONENT PLASMA SPRAYED

    MDR report key: 18131232 · Received November 14, 2023

    Report

    Report Number
    0001822565-2023-03167
    Event Type
    Injury
    Date Received
    November 14, 2023
    Report Date
    March 28, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    UDI-DI
    00889024271357
    PMA / PMN Number
    K181307
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: CATALOG #: 00840009000, UMERAL SCREW KIT 2 HUMERAL SCREWS, LOT # 65143433. CATALOG #: 00840009400, ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING A, LOT # 65310128. CATALOG #: 00840001407, ULNAR COMPONENT PLASMA SPRAYED SIZE 4, LOT # 65251798. H3: THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-03176 AND 0001822565-2023-03177 H3 OTHER TEXT : UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-03176-1. 0001822565-2023-03177-1. H6: COMPONENT CODES: MECHANICAL (G04) - STEM. 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/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT WAS REPORTING LATERAL UPPER ARM PAIN AND OCCASIONALLY HAVING SOME SLIGHT WEAKNESS. THE PATIENT NOTICED PROGRESSIVE INSTABILITY OF THE ELBOW AND FEELS THAT HIS ELBOW IS WORSENING. AUTOGRAFT BONE GRAFTING FROM THE LATERAL COLUMN OF THE HUMERUS TO BE PLACED ALONG THE LONG ANTERIOR FLANGE OF THE HUMERUS COMPONENT. HUMERAL COMPONENT IS LOOSE AND WAS REMOVED BY HAND. NO SIGNS OF INFECTION WERE NOTED. 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 HAD AN INITIAL LEFT TOTAL ELBOW ARTHROPLASTY APPROXIMATELY 3 MONTHS AGO. SUBSEQUENTLY, THEY WERE REVISED ABOUT 3 WEEKS AGO DUE TO PAIN, INSTABILITY, AND ASEPTIC HUMERAL LOOSENING. DURING THE REVISION THE HUMERAL COMPONENT WAS LOOSE AND REMOVED BY HAND. THE HUMERUS WAS EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

    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
    1926923 ZIMMER NEXEL TOTAL ELBOW HUMERAL COMPONENT PLASMA SPRAYED EXTREMITY IMPLANT JDC ZIMMER BIOMET, INC. N/A 65357091 00889024271357

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R SEE H10