BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM

    MDR report key: 6095491 · Received November 11, 2016

    Report

    Report Number
    0001825034-2016-04671
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 18, 2016
    Report Date
    March 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 10 STATES, "FATIGUE FRACTURE OF COMPONENT CAN OCCUR AS A RESULT OF LOSS OF FIXATION, STRENUOUS ACTIVITY, MALALIGNMENT, TRAUMA, NON-UNION, OR EXCESSIVE WEIGHT."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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. MEDICAL PRODUCT- BIOMET COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE BASEPLATE CATALOG#: 115330 LOT#: 831260, BIOMET COMPREHENSIVE LOCKING SCREW CATALOG#: 180502 LOT#:516290, BIOMET COMPREHENSIVE REVERSE SCREW CATALOG#: 115380 LOT#: 552650, BIOMET COMPREHENSIVE LOCKING SCREW CATALOG#: 180502 LOT#: 186940, BIOMET COMPREHENSIVE LOCKING SCREW CATALOG#: 180501, LOT#: 609490, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE CATALOG#: 115310 LOT#: 792370, VERSA-DIAL TAPER CATALOG#: 118001 LOT#: 602730, BIOMET COMPREHENSIVE PRIMARY STEM CATALOG#: 113654 LOT#: 582540, BIOMET HUMERAL BEARING CATALOG#: XL-115363 LOT#: 116180.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. CORRECTED: (DESCRIBE EVENT OR PROBLEM).

    Description of Event or Problem · 1

    PATIENT UNDERWENT A SHOULDER REVISION 5 YEARS POST-IMPLANTATION DUE TO THE TAPER OF THE GLENOID BASEPLATE FRACTURING FROM THE BASE. THE TAPER, GLENOID BASEPLATE AND HUMERAL BEARING WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A SHOULDER ARTHROPLASTY REVISION APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO THE TAPER OF THE HUMERAL TRAY FRACTURING FROM THE BASE. THE FRACTURED TAPER WAS REMOVED AND THE HUMERAL TRAY AND HUMERAL BEARING WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746538 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44MM PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 118250

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R