BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SRS DISTAL BODY WITH SCREW - LEFT

    MDR report key: 7318193 · Received March 6, 2018

    Report

    Report Number
    0001825034-2018-01591
    Event Type
    Injury
    Date Received
    March 6, 2018
    Date of Event
    February 8, 2018
    Report Date
    June 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    Z-1173-2018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 114826, DISC ULNA 4X115 MM LT W/BRNG, 198250. THE 114700, DISC CONDYLE KIT W/ HEXALOBULA, 885680. THE 211252, COMPR SRS 70 MM DST HML BDY LT, 257870. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF PRODUCT RECEIVED. AS RETURNED, THE HUMERAL BODY AND CONDYLE WERE ASSEMBLED TOGETHER, BUT THE HEXALOBULAR SCREWS WERE NOT FULLY THREADED THROUGH THE CONDYLES. THERE IS A SMALL GAP BETWEEN THE CONDYLE AND HUMERAL BODY, PREVENTING THE SCREWS FROM SEATING. THE PRODUCTS WERE DISASSEMBLED AND DIMENSIONAL ANALYSIS WAS PERFORMED. THE DEVICE WAS FOUND NON-CONFORMING. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO INADEQUATE INSPECTION METHODS. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL ELBOW RECONSTRUCTION PROCEDURE, THE DISTAL HUMERAL BODY, CONDYLE KIT, AND ULNA COMPONENT WERE UNABLE TO BE ASSEMBLED. THIS ISSUE WAS FOUND ON THE BACK TABLE WHILE TESTING THE COUPLING OF THE DEVICES. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM, DELAYING THE PROCEDURE GREATER THAN 60 MINUTES. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162512 COMPREHENSIVE SRS DISTAL BODY WITH SCREW - LEFT ELBOW, PROSTHESIS KWT ZIMMER BIOMET, INC. N/A 257870

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R