BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.75 MM FIXED LOCKING SCREW 3.5 HEX

    MDR report key: 8078450 · Received November 16, 2018

    Report

    Report Number
    0001825034-2018-10741
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 18, 2018
    Report Date
    May 2, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K130390
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. HOWEVER, A CONTRIBUTING CONDITION COULD BE THE NOTED POOR GLENOID BONE STOCK. 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). CONCOMITANT MEDICAL PRODUCTS: 010000589, COMPREHENSIVE MINI BASEPLATE AND TAPER ADAPTOR, 959370, 180552, 4.75 MM FIXED LOCKING SCREW 3.5 HEX, 018250, 180553, 4.75 MM FIXED LOCKING SCREW 3.5 HEX, 018380, EP-115394, E1 STANDARD +3 MM HUMERAL BEARING, 232030, 115316,VERSA-DIAL GLENOSPHERE +6 MM,657620, 115395,6.5 MM CENTRAL SCREW 3.5 HEX,104240, 113668,COMPREHENSIVE HUMERAL STEM¿REVISION,831300, 115370,COBALT CHROME STANDARD HUMERAL TRAY,328150. FOREIGN COUNTRY: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT HAD INITIAL COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, PATIENT WAS REVISED FOR THE SECOND TIME AFTER ONE (1) YEAR POST INITIAL SURGERY DUE TO LIMITED BONE STOCK IN THE LATERAL SCAPULA, RESULTING IN BASEPLATE FAILURE. DURING REVISION SURGERY, A BROKEN SCREW WAS FOUND WHICH WAS UNABLE TO BE REMOVED AND HENCE WAS RETAINED. WEAR WAS OBSERVED ON HUMERAL BEARING DUE TO THE CONTACT OF THE BEARING ON THE EDGE OF THE GLENOSPHERE AFTER THE BASEPLATE HAD DISLODGED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918910 4.75 MM FIXED LOCKING SCREW 3.5 HEX PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 151500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R