BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE ARCOM XL 44-36 STANDARD HUMERAL BEARING

    MDR report key: 7779347 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-05128
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    February 26, 2016
    Report Date
    December 18, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT 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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED WITH OPERATIVE NOTES RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED WITH NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES IDENTIFIED. ROOT CAUSE WAS UNABLE TO 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WENT IN FOR A HUMERAL FRACTURE REPAIR. DURING THIS PROCEDURE, THE SURGEON CHECKED THE GLENOSPHERE FOR LOOSENING DUE TO LARGE AMOUNTS OF INFERIOR SCAPULAR NOTCHING. THE SURGEON FOUND THE GLENOSPHERE TO BE STABLE, HOWEVER, THE INFERIOR SCREW WAS COMPROMISED. DUE TO THE STABILITY OF THE REMAINING SCREWS, NO DEVICES WERE REVISED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617311 COMPREHENSIVE ARCOM XL 44-36 STANDARD HUMERAL BEARING PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 745250

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other