BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 FEM HEAD ORTHINOX 28+4

    MDR report key: 3070779 · Received April 22, 2013

    Report

    Report Number
    0002249697-2013-01345
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 25, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN V40 ALUMINA HEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED THE EXETER STEM IS BROKEN APPROXIMATELY AT THE BASE OF THE FEMORAL HEAD. THE FEMORAL HEAD IS STILL ATTACHED TO THE TRUNNION OF THE STEM. BASED ON THE PROVIDED INFORMATION, THE REPORTED FEMORAL HEAD DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT A REVISION FOR A BROKEN EXETER STEM TOOK PLACE ON (B)(6) 2013 IN (B)(6). THE PATIENT HAD PRIMARY DONE IN 2011 IN (B)(6). IT WAS REPORTED THAT THE PATIENT TWISTED HIS HIP WHILE CLOSING A GATE. THE STEM BROKE AT THE NECK AND THEREFORE, ALSO WORE AWAY PART OF THE POLY LINER. THE SURGEON HAD TO PERFORM A REVISION OF THE STEM, HEAD AND LINER.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT A REVISION FOR A BROKEN EXETER STEM TOOK PLACE ON (B)(6) 2013 IN (B)(6). THE PATIENT HAD PRIMARY DONE IN 2011 IN MERLIN PARK. IT WAS REPORTED THAT THE PATIENT TWISTED HIS HIP WHILE CLOSING A GATE. THE STEM BROKE AT THE NECK AND THEREFORE ALSO WORE AWAY PART OF THE POLY LINER. THE SURGEON HAD TO PERFORM A REVISION OF THE STEM, HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172942 V40 FEM HEAD ORTHINOX 28+4 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G2835367

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R