BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER

    MDR report key: 7779323 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-05033
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 31, 2014
    Report Date
    July 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICE WAS RETURNED FOR EXAMINATION. MEDICAL RECORDS WERE REVIEWED AND CONFIRMED DEVICE DISASSOCIATION AND DISLOCATION WITH ASSOCIATED METALLOSIS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO RELATED DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE REMAINS UNDETERMINED. 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 · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. A CONTRIBUTING CONDITION TO THE EVENT IS PATIENT WAS BEING LIFTED UNDERNEATH HER ARM PITS FOR TRANSPORTATION AND FELT A POP. 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 TREND.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT TOTAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT'S GLENOSPHERE DISASSOCIATED. THE PATIENT EXPERIENCED DISLOCATION OF THE SHOULDER AS WELL AS POLY WEAR AND LOSS OF FUNCTION WITH THE ARM. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CSR HUMERAL TRAY ¿ CAT. NO. 115340, LOT NO. 492370, CSR SHOULDER STEM ¿ CAT. NO. 113648, LOT NO. 104520, CSR GLENOSPHERE ¿ CAT. NO. 115310, LOT NO. 609790, CSR HUMERAL BEARING ¿ CAT. NO. XL-115363, LOT NO. 011140, CSR GLENOSPHERE BASEPLATE ¿ CAT. NO. 115330, LOT NO. 550050, FIXED LOCKING SCREW ¿ CAT. NO. 180501, LOT NO. 468580. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT TOTAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENTS GLENOSPHERE DISASSOCIATED. THE PATIENT EXPERIENCED DISLOCATION OF THE SHOULDER AS WELL AS POLY WEAR. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620332 VERSA-DIAL/COMPREHENSIVE TI STANDARD TAPER PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 534460

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R 115330 COMPREHENSIVE BASEPLATE, LOT 550050