BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TI TRAY 44MM

    MDR report key: 7779306 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-05011
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    January 25, 2017
    Report Date
    December 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    Z-1103-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICE WAS RETURNED FOR REVIEW, HOWEVER IT IS KNOWN THIS PRODUCT/LOT CODE COMBINATION HAS BEEN PREVIOUSLY RECALLED FROM THE MARKET UNDER Z-1103-2017. OPERATIVE NOTES CONFIRM THE REPORT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE IS ATTRIBUTED TO A DESIGN DEFICIENCY. 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 INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VERSA-DIAL GLENOSPHERE STANDARD 41 MM [CATALOG 115320; LOT 413710], GLENOID BASEPLATE [CATALOG 115330; LOT 780260], FIXED NON-LOCKING SCREW [CATALOG 180508; LOT 852570], ARCOMXL STANDARD HUMERAL BEARING 44 ¿ 41 MM [CATALOG XL-115366; LOT 125320], CENTRAL SCREW [CATALOG 115382; LOT 447900], FIXED NON-LOCKING SCREW [CATALOG 180508; LOT 852600], FIXED LOCKING SCREW [CATALOG 180501; LOT 447970], VERSA-DIAL TAPER ADAPTOR [CATALOG 118001; LOT 221410], COMPREHENSIVE HUMERAL STEM ¿ MINI 14 MM [CATALOG 113634; LOT 204480], FIXED LOCKING SCREW [CATALOG 180504; LOT 448000]. 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL LEFT REVERSE SHOULDER ARTHROPLASTY PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE HUMERAL TRAY HAD FRACTURED AND HAD SEPARATED. IT WAS ALSO REPORTED THAT DURING THE REVISION, METAL SHAVINGS WERE SEEN IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620115 COMPREHENSIVE REVERSE HUMERAL TI TRAY 44MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 607410

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R