BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE PRIMARY STEM 10MM STANDARD

    MDR report key: 7779324 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-05071
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    February 26, 2016
    Report Date
    December 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVIEW OF OP NOTES FOUND THAT THE PATIENT HAD A BLOOD LOSS OF 1360 CC DURING THE REVISION, AND REQUIRED 1 UNIT OF PRBC TRANSFUSED DURING THE PROCEDURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING 44 MM STANDARD [CATALOG # 115340; LOT 659950]; GLENOID BASEPLATE [CATALOG # 115330; LOT 863590]; ARCOMXL STANDARD HUMERAL BEARING 44 ¿ 36 MM [CATALOG # XL-115363; LOT 745250]; VERSA-DIAL GLENOSPHERE STANDARD 36 MM [CATALOG # 115310; LOT 457000]; HUMERAL STEM STANDARD 10 MM [CATALOG # 113650; LOT 623850]; FIXED NON-LOCKING SCREW 4.75 3.5 HEX 15 MM [CATALOG # 180507; LOT 852390]; FIXED LOCKING SCREW 4.75 MM 3.5 HEX 20 MM [CATALOG # 180501; LOT 851510]; FIXED LOCKING SCREW 4.75 MM X 15 MM [CATALOG # 180500; LOT 468560]; FIXED LOCKING SCREW 4.75 MM 3.5 HEX 15 MM [CATALOG # 180500; LOT 851320]; CENTRAL SCREW 6.5 3.5 HEX 25 MM [CATALOG # 115381; LOT 320020]; VERSA-DIAL TAPER ADAPTOR [CATALOG # 118001; LOT 380360]. 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAD A HUMERAL FRACTURE. DURING THE HUMERAL FRACTURE REPAIR PROCEDURE, THERE WAS A HIGH AMOUNT OF BLOOD LOSS. THE PATIENT WAS GIVEN A UNIT OF PACKED RED BLOOD CELLS. THERE WERE NO COMPLICATIONS REPORTED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620333 COMPREHENSIVE PRIMARY STEM 10MM STANDARD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 623850

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention