BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 40MM/-4

    MDR report key: 3233610 · Received July 18, 2013

    Report

    Report Number
    0002249697-2013-02364
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    March 7, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Removal / Correction Number
    2249697-05/07/2018-003R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT ALLEGED THE PATIENT¿S INJURIES WERE THE RESULT OF THE FEMORAL HEAD AND NOT THE MODULAR NECK-STEM DEVICE THAT WAS ALSO IMPLANTED IN THE PATIENT. MATERIAL ANALYSIS OF THE RETURNED FEMORAL HEAD DID FIND DEBRIS WITHIN THE FEMALE HEAD TAPER, HOWEVER, THE SURFACE OF THE TAPER WAS PRIMARILY UNDAMAGED AND STILL SHOWED THE AS-MANUFACTURED MACHINED SURFACE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT THE PATIENT AFFECTED BY COXARTHRITIS UNDERWENT TO HIP SURGERY WITH ABG MOD. - TRIDENT ON (B)(6) 2012. PATIENT UNDERWENT TO REVISION SURGERY ON (B)(6) 2013 DUE TO PAIN, RUBOR AND TUMESCENCE LOCATED IN THE IMPLANTED AREA, PROBABLY FOR AN ALLERGY REACTION. THE PATIENT RESULTS ALLERGIC TO NICKEL AND PENICILLIN. SAMPLE TAKING OF LIQUID AND TISSUE WILL BE ANALYZED. SURGEON ASKS TO VERIFY IF THERE ARE SIGNIFICANT WEAR EVIDENCE IN THE INTERNAL HEAD MORSE CONE. THE SURGEON REPLACE THE METAL HEAD WITH A BIOLOX DELTA ONE, AND DIDN'T REMOVE THE ABG MODULAR, BECAUSE IN HIS OPINION THE PHLOGOSIS WAS CAUSED BY THE METAL OF THE HEAD AND NOT BY THE MODULAR NECK.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT THE PATIENT AFFECTED BY COXARTHRITIS UNDERWENT TO HIP SURGERY WITH ABG MOD. - TRIDENT ON (B)(6) 2012. PATIENT UNDERWENT TO REVISION SURGERY ON (B)(6) 2013 DUE TO PAIN, RUBOR AND TUMESCENCE LOCATED IN THE IMPLANTED AREA, PROBABLY FOR AN ALLERGY REACTION. THE PATIENT RESULTS ALLERGIC TO NICKEL AND PENICILLIN. SAMPLE TAKING OF LIQUID AND TISSUE WILL BE ANALYZED. SURGEON ASKS TO VERIFY IF THERE ARE SIGNIFICANT WEAR EVIDENCE IN THE INTERNAL HEAD MORSE CONE. THE SURGEON REPLACE THE METAL HEAD WITH A BIOLOX DELTA ONE, AND DIDN'T REMOVE THE ABG MODULAR, BECAUSE IN HIS OPINION THE PHLOGOSIS WAS CAUSED BY THE METAL OF THE HEAD AND NOT BY THE MODULAR NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335881 V40 COCR LFIT HEAD 40MM/-4 HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES LPH STRYKER ORTHOPAEDICS-MAHWAH MHNKT9

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R