BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE CENTRAL SCREW

    MDR report key: 6436667 · Received March 27, 2017

    Report

    Report Number
    0001825034-2017-02019
    Event Type
    Injury
    Date Received
    March 27, 2017
    Report Date
    October 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - COMPREHENSIVE REVERSE SHOULDER GLENOID BASEPLATE CAT#: 115330 LOT#: 061710, COMPREHENSIVE PRIMARY STEM CAT#: 113647 LOT#: 726560, COMPREHENSIVE REVERSE HUMERAL TI TRAY CAT#: 115340 LOT#: 541900, HUMERAL BEARING CAT#: XL-115363 LOT#: 778020, VERSA-DIAL/COMP TI TAPER CAT#: 118001 LOT#: 456370, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE CAT#: 115310 LOT#: 823240, COMPREHENSIVE LOCKING SCREW CAT#: 180503 LOT#: 988300, COMPREHENSIVE LOCKING SCREW CAT#: 180501 LOT#: 153550, COMPREHENSIVE REVERSE FIXED LOCKING SCREW CAT#: 180500 LOT#: 153540. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS [REMAINS IMPLANTED]; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-02018.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. X-RAYS SHOW: BROKEN CENTRAL SCREW, LOOSE GLENOID COMPONENT, WHICH MAY HAVE APPARENTLY ROTATED ANTERIORLY, FRACTURE OF THE ACROMION, MULTIPLE POSTERIOR RIGHT RIB FRACTURES, AND GENERALIZED OSTEOPENIA. FRACTURES OF THE ACROMION AND MULTIPLE POSTERIOR RIGHT-SIDED RIB FRACTURES ARE CONSISTENT WITH A TRAUMATIC EVENT, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT OF FRACTURED CENTRAL SCREW. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE. APPROXIMATELY 4.5 YEARS SUBSEQUENT, THE CENTRAL BASEPLATE SCREW WAS NOTED TO HAVE BROKEN AND BASEPLATE HAS LOOSENED. NO REVISION HAS BEEN SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SHOULDER PROCEDURE. APPROXIMATELY 4.5 YEARS SUBSEQUENT, THE CENTRAL BASEPLATE SCREW WAS NOTED TO HAVE BROKEN AND BASEPLATE HAS LOOSENED. NO REVISION HAS BEEN SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE. X-RAYS INDICATE FRACTURED RIBS AND ACROMION, WHICH ARE CONSISTENT WITH TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219205 COMPREHENSIVE REVERSE CENTRAL SCREW PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS 193940

    Patients

    Seq Age Sex Outcome Treatment
    1 Other