BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TRAY 44MM

    MDR report key: 6412735 · Received March 17, 2017

    Report

    Report Number
    0001825034-2017-01665
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    January 25, 2017
    Report Date
    September 5, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 115330, LOT NUMBER: 686000, DESCRIPTION: COMPREHENSIVE REVERSE SHOULDER GLENOID BASPLATE; 118001, 910710, VERSA-DIAL/COMPREHENSIVE STANDARD TAPER ADAPTER; 115383, 950390,  COMPREHENSIVE REVERSE CENTRAL SCREW 6.5X35MM; 115320, 254180, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE 41MM; 180502, 071970, COMPREHENSIVE LOCKING SCREW 4.75X25MM QTY 2; 113633, 949970,  COMPREHENSIVE PRIMARY STEM 13MM MINI; XL-115366, 383910, ACROM XL 44-41 STANDARD HUMERAL BEARING. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS AND ONCE IT HAS BEEN COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER REVISION PROCEDURE APPROXIMATELY FIVE YEARS POST-IMPLANTATION DUE TO THE HUMERAL TRAY FRACTURING AT THE TAPER JUNCTION. THE FRACTURED TAPER PORTION BECAME COLD WELDED IN THE STEM; RESULTING IN A GREATER THAN THIRTY MINUTE DELAY IN THE PROCEDURE DUE TO THE STEM HAVING TO BE REMOVED, ALONG WITH THE TRAY AND BEARING COMPONENTS. NO ADDITIONAL PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195852 COMPREHENSIVE REVERSE HUMERAL TRAY 44MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 981140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R