BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE VERSA-DIAL 46X24X47 HUMERAL HEAD

    MDR report key: 7851914 · Received September 6, 2018

    Report

    Report Number
    0001825034-2018-08694
    Event Type
    Injury
    Date Received
    September 6, 2018
    Date of Event
    August 9, 2018
    Report Date
    December 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: THE COMPLAINT IS CONFIRMED BASED ON THE X-RAYS WHICH WERE RECEIVED AND REVIEWED. PER THE REVIEW HUMERAL HEAD APPEARS SUPERIORLY POSITIONED AS NOTED. THE HEAD COMPONENT IS LARGE. BONE QUALITY APPEARS MILDLY OSTEOPENIC. NO EVIDENCE OF AVN OR OTHER CONTRIBUTING FACTOR APART FROM THOSE NOTED. NO EVIDENCE OF LOOSENING OR SUBSIDENCE. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS ADDITIONALLY REPORTED THROUGH X-RAY REVIEW THAT THE IMPLANT WAS OVERSIZED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113954 MD HYBRID GLENOID BASE 4 MM 429720; PT-113950 PT HYBRID GLEN POST REGENEREX 574600; 113635 COMP PRIMARY STEM 15 MM MINI 680050; 113046 VERSA-DIAL 46X24X47 HUM HEAD 079020. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, NO PRODUCT DEFICIENCY ALLEGED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TO UNDERGO A REVISION SURGERY OF THEIR SHOULDER ARTHROPLASTY DUE TO ROTATOR CUFF FAILURE APPROXIMATELY SIX (6) MONTHS POST IMPLANTATION. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693145 COMPREHENSIVE VERSA-DIAL 46X24X47 HUMERAL HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 079020

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R