BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MD HYBRID GLENOID BASE 4MM

    MDR report key: 7776517 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-04441
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    June 13, 2018
    Report Date
    February 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW UP REPORT IS BEING REPORTED BASED ON THE ADDITIONAL INFORMATION RECEIVED. THE COMPLAINT CAN BE CONFIRMED BASED ON THE RETURNED DEVICES. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWS FRACTURED GLENOID AND THE POST HAVING THE BROKEN PIECE. THE POST HAS GOOD BONE GROWTH. THE GLENOID HAS WEAR MARKS ALL OVER THE ARTICULATING SURFACE. SEM ANALYSIS OF THE FRACTURED PIECE IDENTIFIED, THE GLENOID BASE INSERT LIKELY FRACTURED DUE TO FATIGUE. MOST OF THE FRACTURE SURFACE APPEARED TO HAVE SMEARED POST FRACTURE. EDS ELEMENTAL ANALYSIS SHOWED THAT IT IS CONSISTENT WITH MATERIAL SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO RELATED DEVIATIONS OR ANOMALIES. ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): PT-113950 PT HYBRID GLEN POST REGENEREX 000760; 118001 VERSA-DIAL/COMP TI STD TAPER 926580; 113042 VERSA-DIAL 46X18X53 HUM HEAD 681390; 113630 COMP PRIMARY STEM 10MM MINI 932080; 110003484 ACCESS 3.2MM THD STEINMANN 9 957650; 405800 COMP. REV SHLDR 9 IN STEINMANN 898870. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. 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 - 2018 - 04442.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION RIGHT SHOULDER ARTHROPLASTY DUE TO GLENOID BASEPLASTE DISASSOCIATION FROM THE REGENEREX POST. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620182 MD HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 904130

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R