BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM COLLARED HA COATED STD STEM SIZE 4

    MDR report key: 7446376 · Received April 20, 2018

    Report

    Report Number
    3005180920-2018-00257
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    March 23, 2018
    Report Date
    April 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804595
    PMA / PMN Number
    K121011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 APRIL 2018; LOT 172626: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 OCTOBER 2017. EXPIRATION DATE: 2022-10-01; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON 19 APRIL 2018: EVALUATING THE IMAGES ATTACHED TO THIS COMPLAINT IT SEEMS THAT THE BROACH IS FUNCTIONALLY CONFORM. THERE ARE ONLY SOME LITTLE SCRATCHES VISIBLE ON THE BROACH SURFACE, DUE TO THE USAGE, THAT WE CAN CONSIDER ACCEPTABLE. THERE IS NO EVIDENCE RELATED TO THE FACT THAT THE SURGEON WASN'T ABLE TO INSERT THE STEM SIZE 4 IN THE FEMUR AFTER CANAL PREPARATION. VISUAL INSPECTION PERFORMED BY R&D PRODUCT MANAGER ON 20 APRIL 2018: THE STEM APPEARED WITHOUT ANY PARTICULAR SIGN, EXCEPT FOR THE SCRATCHES RELATED TO THE DIFFICULT REMOVAL (SIGNS UNDER THE COLLAR, GROOVE IN THE NECK). FROM THE RECEIVED PIECE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    AFTER HAVING USED THE BROACH SIZE #4, THE SURGEON TRIED TO IMPLANT THE STEM SIZE #4, BUT IT FLOATED ABOUT 7MM UP. THE SURGEON REPLACED IT WITH A STEM SIZE #3. IT TOOK ABOUT 40 MINUTES FOR RETRIEVING. THE BROACH WAS NOT DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289664 STEM COLLARED HA COATED STD STEM SIZE 4 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 172626 07630030804595

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other