BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM

    MDR report key: 6039391 · Received October 19, 2016

    Report

    Report Number
    0001825034-2016-04174
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Report Date
    December 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, IT STATES, "THE SURGEON IS TO BE THOROUGHLY FAMILIAR WITH THE IMPLANTS, INSTRUMENTS AND SURGICAL TECHNIQUE PRIOR TO PERFORMING SURGERY." (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K060716. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04172 / 04173 / 04174).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED; HOWEVER, PHOTOS WERE RECEIVED WHICH CONFIRMED THE DIFFERENCE IN HEIGHT. THIS DIFFERENCE WAS FURTHER CONFIRMED VIA LAYOUTS PERFORMED BY DEVELOPMENT; HOWEVER, THE DIFFERENCE IN HEIGHT STILL SUGGESTS THE APPROPRIATE IMPLANT SIZE TO THE SURGEON. THE DEVICES WERE DESIGNED ACCORDING TO SPECIFICATIONS AND OPERATED AS INTENDED. 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 · 1

    DURING THE SHOULDER ARTHROPLASTY, A HUMERAL STEM AND VERSA-DIAL HEAD WERE USED. SURGEON STATED THAT HEIGHT OF TRIAL HUMERAL HEAD AND TRIAL HUMERAL STEM WERE DIFFERENT FROM THE HEIGHT OF IMPLANT HUMERAL HEAD AND HUMERAL STEM. THERE WAS NO PATIENT INJURY OR DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693706 COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD - VARIABLE OFFSET 42MM X 18MM X 46MM PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A 670650

    Patients

    Seq Age Sex Outcome Treatment
    1