BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM

    MDR report key: 6491248 · Received April 13, 2017

    Report

    Report Number
    0001825034-2017-02489
    Event Type
    Injury
    Date Received
    April 13, 2017
    Date of Event
    January 18, 2017
    Report Date
    January 23, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOS. REVIEW OF THE RETURNED PHOTOS SHOWED: THE STEM EXHIBITED FEW GOUGES. THE BROKEN FEMALE TAPER OF THE TRAY REMAINED IN THE STEM AND HENCE SURGEON HAD TO USE ALTERNATE METHOD TO EXTRACT THE STEM WHICH CAUSED THE GOUGES ON THE STEM. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE ROOT CAUSE WAS DETERMINED TO BE THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. IT IS STATED IN REVISION OP-NOTES THAT "THE SHOULDER NOW EXPOSED, WE MADE AN ATTEMPT TO TRY TO REMOVE THE STEM WITHIN THE TRUNNION OF THE HUMERAL IMPLANT AND WE DID THIS WITH A 3.2 METAL CARBIDE TIP AND WE COULD NOT AS DISASSOCIATED THAT WAY WE CUT A GROOVE, SO WE COULD TRY TO USE THE BLADE TYPE OF SCREWS OR DISLODGER: ALL THESE WERE UNSUCCESSFUL. AT THIS POINT, THEN THE STEM HAD TO BE EXTRACTED AND THIS WAS DONE THROUGH A TRAPDOOR WINDOW WHICH WAS APPROXIMATELY 5 X 1 CM RECTANGLE ALONG THE ANTERIOR EXPOSURE OF THE PROXIMAL HUMERUS." DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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). MEDICAL DEVICES-COMPREHENSIVE SCREW CATALOG#:180509 LOT#: 852650, COMPREHENSIVE REVERSE SHOULDER GLENOID BASEPLATE CATALOG#:115330 LOT#:524560, COMPREHENSIVE REVERSE CENTRAL SCREW CATALOG#:115383 LOT#: 256750, COMPREHENSIVE NON LOCKING SCREW CATALOG#:180509 LOT#: 852620, COMPREHENSIVE LOCKING SCREW CATALOG#:180504 LOT#:029360, COMPREHENSIVE LOCKING SCREW CATALOG#:180505 LOT#: 852240, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE CATALOG#:115310 LOT#:258260, VERSA DIAL TAPER CATALOG#: 118001 LOT#:927850. CUSTOMER HAS NOT YET INDICATED IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01423, 0001825034-2017-02483, 0001825034-2017-02487.

    Description of Event or Problem · 1

    DURING A SHOULDER ARTHROPLASTY REVISION PROCEDURE, IT IS REPORTED THAT THE SURGEON WAS UNABLE TO REMOVE THE FRACTURED TRUNNION OF THE HUMERAL TRAY FROM THE STEM. AS A RESULT, THE STEM HAD TO BE REMOVED FROM THE PATIENT. OPERATIVE NOTES FURTHER STATE THAT THE BONE WAS THIN POSTERIORLY AND WAS CONSIDERED FRACTURED AS A RESULT. THE BONE WAS REINFORCED AND RECONSTRUCTED, AND A FRACTURE STEM WAS CEMENTED INTO PLACE TO COMPLETE THE PROCEDURE, WITH NO ADDITIONAL PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270858 COMPREHENSIVE SHOULDER SYSTEM PRIMARY MINI LENGTH SHOULDER STEM PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS NI 879400

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention