BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO B-MTRC MP FP SO 9

    MDR report key: 13181061 · Received January 6, 2022

    Report

    Report Number
    0001825034-2022-00057
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 21, 2021
    Report Date
    March 16, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304697768
    PMA / PMN Number
    K143009
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 193010 ECHO B-MTRC MP FP SO 10 LOT#: 812450, CATALOG#: 110017102 G7 FINNED 3 HOLE SHELL 50D LOT#: 7107431, CATALOG#: 00-6250-065-30 BONE SCREW 6.5X30 SELFTAP LOT#: J7126859, CATALOG#: 110024462 G7 DUAL MOBILITY LINER 40MM D LOT#: 633890, CATALOG#: 650-1065 CER OPTION TYPE 1 TPR SLEVE -3 LOT#: 3065028, CATALOG#: 110031010 VIVACIT-E DM BEARING 28X40MM LOT#: 64782770, CATALOG#: 650-1055 CER BIOLOXD OPTION HD 28MM LOT#: 3087405. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT 0001825034-2022-00058. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE ECHO B-MTRC MP FP WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION, THE DEVICE HAS DAMAGE IN TO LOCATIONS ON THE LIP OF THE THREADED HOLE. THERE IS NO OTHER VISIBLE DAMAGE TO THE DEVICE. THE HEIGHT WAS CHECKED WITH THE COMPARATOR TO THE PRINT AND FOUND WITHIN THE GIVEN DIMENSIONS. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE SURGEON HAD STARTED UTILIZING A 10MM BROACH AND THEN ELECTED TO IMPLANT A 9MM STEM WHICH IS CONSIDERED OFF LABEL AND WOULD HAVE CAUSED THE ISSUES WITH THE STEM SUBSIDING. THE ECHO BI-METRIC MICROPLASTY HIP STEM SURGICAL TECHNIQUE STATES UNDER THE STEM INSERTION SECTION SELECT THE ECHO BI-METRIC MICROPLASTY FEMORAL IMPLANT THAT CORRESPONDS TO THE SIZE OF THE FINAL BROACH. THE 9MM STEM WAS REMOVED AND A 10MM STEM WAS IMPLANTED WITH NO FURTHER COMPLICATIONS. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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 DURING AN INITIAL HIP ARTHROPLASTY, THE STEM SUBSIDED. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    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
    991777 ECHO B-MTRC MP FP SO 9 PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 175900 00880304697768

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other