BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 36IDX54OD

    MDR report key: 3180553 · Received June 20, 2013

    Report

    Report Number
    1818910-2013-19411
    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
    LPH
    PMA / PMN Number
    K033273
    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

    ADDITIONAL INFO CATALOG AND LOT NUMBER. LITIGATION ALLEGES PAIN, DISCOMFORT, LIMITED MOBILITY, GRINDING SENSATIONS, AUDIBLE SQUEAKING AND TOXIC COBALT AND CHROMIUM METAL DEBRIS TO BE RELEASED INTO THE TISSUE. THE INVESTIGATION IS ONGOING. 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

    (B)(4).

    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

    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

    UPDATED DOR. ADDED LAWYER IN THE ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280328 PINN MAR +4 10D 36IDX54OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US B2ND81000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention