BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPREHENSIVE MINI STEM

    MDR report key: 6822529 · Received August 25, 2017

    Report

    Report Number
    0001825034-2017-06768
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Report Date
    March 2, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MD HYBRID GLENOID BASE 4MM, PART # 113954, LOT 3 605680. VERSA-DIAL 46X18X53 HUM HEAD, PART # 113042, LOT # 621170. VERSA-DIAL/COMP TI STD TAPER PR ADAPTOR, PART # 118001, LOT # 685590. PT HYBRID GLEN POST REGENEREX, PART # PT-113950, LOT # 701940. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 06766, 0001825034 - 2017 - 06767, 0001825034 - 2017 - 06769, 0001825034 - 2017 - 06818. PATIENT RECEIVED A LETTER NOTIFYING THE PART IS BEEN RECALLED. RECALL NUMBER IS NOT AVAILABLE AT THIS TIME. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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. 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

    IT IS REPORTED THAT PATIENT IS EXPERIENCING PAIN 4 MONTHS POST-IMPLANTATION THE SHOULDER IS LOCKING UP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600862 COMPREHENSIVE MINI STEM PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 785680

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other