BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPREHENSIVE PRIMARY STEM

    MDR report key: 9732791 · Received February 20, 2020

    Report

    Report Number
    0001825034-2020-00741
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    February 3, 2016
    Report Date
    March 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K060692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE STEM WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE STEM WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VERSA-DIAL 54X21X64 HUM HEAD CAT# 113063 LOT# 763960. VERSA-DIAL/COMP TI STD TAPER CAT# 118001 LOT# 957350. PT HYBRID GLEN POST REGENEREX CAT# PT-113950 LOT# 376020. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL SHOULDER ARTHROPLASTY (TSA). ON FOLLOW UP IT WAS NOTED THAT THERE WAS A DISPLACED FRAGMENT OF THE LESSER TUBEROSITY OF THE HUMERUS. APPROXIMATELY 5 MONTHS AFTER THE INITIAL TSA, AN OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS PERFORMED TO REPAIR THE FRACTURE. OPERATIVE RECORDS INDICATE THAT THE HUMERAL HEAD AND GLENOID COMPONENTS WERE STABLE. FURTHER, A 1.0 MM TITANIUM COMPETITOR NEEDLE CABLE WAS PASSED THROUGH THE BONE TUNNELS CREATED. THE NEEDLE CABLE WAS PASSED AROUND THE LESSER TUBEROSITY FRAGMENT IN A CERCLAGE FASHION AND THEN THE CABLE WAS THREADED. 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
    194907 COMPREHENSIVE PRIMARY STEM PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. NI 868740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R