BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR RGX AUG - SMALL

    MDR report key: 7560476 · Received June 1, 2018

    Report

    Report Number
    0001825034-2018-03745
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    January 19, 2017
    Report Date
    July 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE IDENTIFIER (UDI) #: (B)(4). CATALOG# 211232, COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR STEM - 10X75MM, LOT # 215950, CATALOG# 211222, COMPREHENSIVE SEGMENTAL REVISION SYSTEM TUMOR BODY - 61MM, LOT # 543430, CATALOG# 211278, COMPREHENSIVE SEGMENTAL REVISION SYSTEM SEAS HUMERAL HEAD 48X19, LOT # 886950. REPORT SOURCES: (B)(6). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG# 211278, COMPREHENSIVE SEGMENTAL REVISION SYSTEM SEAS HUMERAL HEAD 48X19, LOT # UNKNOWN, CATALOG# 211232, COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR STEM - 10X75MM, LOT # UNKNOWN, CATALOG# 211222, COMPREHENSIVE SEGMENTAL REVISION SYSTEM TUMOR BODY - 61MM, LOT # UNKNOWN. FOREIGN: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034-2018-03744, 0001825034-2018-03746, 0001825034-2018-03747. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HUMERUS ARTHROPLASTY PATIENT SUFFERED AN INJURY TO A NERVE CAUSING INCOMPLETE AXILLARY NERVE DYSFUNCTION. THE PATIENT ALSO SUFFERED FROM A HEMATOMA TWO (2) DAYS POST-OPERATIVELY. THE PATIENT WAS PLACED ON ANTIBIOTICS TO TREAT THE HEMATOMA. BOTH OF THESE ISSUES WERE RESOLVED. NO FURTHER COMPLICATIONS DURING PROCEDURE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405283 COMPREHENSIVE SEGMENTAL REVISION SYSTEM MODULAR RGX AUG - SMALL PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 664510

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R