BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE HUMERAL TRAY TAPER STEM EXTRACTOR

    MDR report key: 6691648 · Received July 6, 2017

    Report

    Report Number
    0001825034-2017-04590
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 6, 2017
    Report Date
    October 4, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWB
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 PRODUCTS: SCREW CATALOG#:115383 LOT#:552680, SCREW CATALOG#:180500 LOT#:836390, SCREW CATALOG#:180500 LOT#:669780, SCREW CATALOG#:180501 LOT#:730570, SCREW CATALOG#: 180502 LOT#:605670, GLENOSPHERE CATALOG#:115320, LOT#:890140, PIN CATALOG#:405800 LOT#: 914650, DRILL CATALOG#:405889 LOT#:209110, DRILL CATALOG#:405883 LOT#:316690, TAPER CATALOG#:118001 LOT#:927470, BASEPLATE CATALOG#:115330 LOT#:926700, BEARING CATALOG#:XL-115366 LOT#:585890, STEM CATALOG#:113631 LOT#:423170, TRAY CATALOG#: 115340 LOT#: 983880. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04550, 0001825034-2017-04588. 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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION PROCEDURE, DURING STEM REMOVAL, THE STEM EXTRACTOR INSTRUMENT FRACTURED. THE SURGERY WAS COMPLETED BY USING A SMALL DRILL BIT TO REMOVE BONE FROM THE PROXIMAL END OF THE STEM AND USED VICE GRIPS TO REMOVE THE STEM. ALL DEVICE FRAGMENTS WERE RETRIEVED. A NEW STEM OF THE SAME SIZE AND A +5 BEARING AND NEW TRAY WERE IMPLANTED TO COMPLETE THE PROCEDURE. THE PHYSICIAN ADMITS TO HAVING HIT THE INSTRUMENT PRIOR TO FRACTURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY REVISION PROCEDURE, THE TAPER FROM THE FRACTURED HUMERAL TRAY WAS STUCK IN THE STEM AND THE REMOVAL TOOL WAS NOT ABLE TO REMOVE IT AFTER SEVERAL ATTEMPTS. AS A RESULT, IT BECAME NECESSARY TO REMOVE THE HUMERAL STEM. DURING STEM REMOVAL, THE STEM EXTRACTOR INSTRUMENT FRACTURED. THE SURGERY WAS COMPLETED BY USING A SMALL DRILL BIT TO REMOVE BONE FROM THE PROXIMAL END OF THE STEM AND USED VICE GRIPS TO REMOVE THE STEM. A NEW STEM OF THE SAME SIZE AND A +5 BEARING AND NEW TRAY WERE IMPLANTED TO COMPLETE THE PROCEDURE. THIS MALFUNCTION ENDED UP CAUSING AN APPROXIMATE DELAY OF THIRTY FIVE (35) TO FORTY FIVE (45) MINUTES IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471512 COMPREHENSIVE HUMERAL TRAY TAPER STEM EXTRACTOR ORTHOPEDIC SURGICAL MANUAL INSTRUMENT HWB BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R