BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD 50MM X 24MM X 52MM

    MDR report key: 6064758 · Received October 28, 2016

    Report

    Report Number
    0001825034-2016-04308
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    April 20, 2010
    Report Date
    October 28, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CONCOMITANT MEDICAL PRODUCT ¿ PC HYBRID GLEN POST- POLY, CAT#: 113951 LOT#: 819170; COMP PRIMARY STEM 13MM STD, CAT#: 113653 LOT#: 046730; VERSA-DIAL/COMP TI STD TAPER, CAT#: 118001 LOT#: 828670; MD HYBRID GLENOID BASE 4MM, CAT#: 113954 LOT#: 078260; COBALT G-HV BONE CEMENT 40G, CAT#: 402283 LOT#: 951600. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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

    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 OR DEVIATION. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04308 / 02500).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN A THE TIME OF THE INITIAL MEDWATCH. (B)(6). REPORT DATE SEP 1, 2017. REC'D BY MFR - AUG 7, 2017

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTION MADE IN INITIALLY REPORTED MDR 0001825034 - 2016 - 04308 AS ADVERSE EVENT, NOT PRODUCT PROBLEM. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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

    PATIENT UNDERWENT A SHOULDER REVISION DUE TO ROTATOR CUFF ISSUES APPROXIMATELY 4 MONTHS POST-IMPLANTATION. NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING PATIENT CONDITION OR OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715515 VERSA-DIAL SHOULDER SYSTEM MODULAR HEAD 50MM X 24MM X 52MM PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 266100

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R