BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 HI OFF

    MDR report key: 7562749 · Received June 1, 2018

    Report

    Report Number
    1818910-2018-61175
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    January 10, 2013
    Report Date
    May 4, 2018
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    LPH
    UDI-DI
    10603295060079
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, DIFFICULTY AMBULATING/LIMITED MOBILITY, AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM AND PARTICLES TO BE RELEASED INTO THE PLAINTIFF'S BLOOD, TISSUE, AND BONE. UPDATE: 5/7/2013 PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE AD 04 MAY 2018: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND STICKER SHEETS. PPF HAS NO NEW ALLEGATIONS REPORTED. THERE IS NO REPORT OF REVISION. THE LAW FIRM NAME, ASSOCIATED CONTACT, MANUFACTURING DATE, PATIENT INITIALS AND PATIENT HARM WERE UPDATED. ADDED THE EXPIRATION DATE AND UDI. AN IMPACTED PRODUCT RECORD FOR THE STEM WAS ADDED DUE TO THE ALLEGED OF TOXIC COBALT-CHROMIUM (B)(4):LPH/K001991). DOI: JAN 20, 2005 : DOR: NOT REPORTED (RIGHT HIP) THIS PC IS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401816 SUMMIT POR TAPER SZ6 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDIC INC, 1818910 Y81HB1000 10603295060079

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention