BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3180561 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19413
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    March 1, 2011
    Report Date
    June 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UPDATE 11/15/2016 - PFS AND MEDICAL RECORDS RECEIVED 11/15/2016. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, LITIGATION ALLEGES PATIENT'S LEG WOULD "GIVE OUT" AND SHE WOULD FALL. THE MEDICAL RECORDS INDICATE PAIN IN GROIN, TINGLING/NUMBNESS LATERAL DISTAL THIGH, AND THAT HER KNEE WOULD BUCKLE. REVISION OPERATIVE NOTE INDICATES CUP MALPOSITION, EXCESSIVE POLYETHYLENE WEAR, AND POSTERIOR IMPINGEMENT, BUT CONTAIN NO INFORMATION TO SUPPORT AUDIBLE SQUEAKING, OR TOXIC COBALT AND CHROMIUM METAL DEBRIS RELEASE. IT IS NOTED THAT THE PATIENT POSSESSED A POLYETHYLENE LINER BEFORE REVISION, WHICH WOULD NOT CONTRIBUTE TO METAL ION TOXICITY OR METAL DEBRIS. NO LABS FOR METAL ION LEVELS PRESENT. STEM AND CUP ADDED TO COMPLAINT, AND IMPLANT BEARING WEAR-POLYETHYLENE, IMPLANT POSITION-MALPOSITION, AND IMPINGEMENT HARMS ADDED TO COMPLAINT AND FDA CODING.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, DISCOMFORT, LIMITED MOBILITY, GRINDING SENSATIONS, AUDIBLE SQUEAKING AND TOXIC COBALT AND CHROMIUM METAL DEBRIS TO BE RELEASED INTO THE TISSUE.

    Description of Event or Problem · 1

    UPDATED DOR. ADDED LAWYER IN THE ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281219 ARTICULEZE M HEAD 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 2549283

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention