BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 STD OFF

    MDR report key: 2900895 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-00758
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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

    UPDATE: 12/10/12, PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT A CRACK IN THE FEMUR WAS NOTICED DURING IMPACTION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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). ADDED: (PATIENT).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM SEVERE PAIN, DISCOMFORT, LIMITED MOBILITY, AND A CONSTANT LIMP.

    Description of Event or Problem · 1

    UPDATE JUL 24, 2017: LEGAL MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY LITIGATED, PFS ALLEGES DIFFICULTY IN WALKING AND CARRYING DAILY ACTIVITIES. AFTER REVIEW OF THE MEDICAL RECORDS, LAB RESULT FOR METAL ION LEVELS WERE BELOW 7PPB. THERE IS NO REVISION REPORTED AT THIS TIME. THIS COMPLAINT WAS UPDATED ON AUG 8, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9386 SUMMIT POR TAPER SZ6 STD OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. 1818910 X85C41000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other