BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 STD OFF

    MDR report key: 7625086 · Received June 21, 2018

    Report

    Report Number
    1818910-2018-62833
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    November 26, 2013
    Report Date
    June 20, 2018
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    LPH
    UDI-DI
    10603295059370
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    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

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, DISCOMFORT, LIMITED MOBILITY AND TOXIC LEVELS OF COBALT AND CHROMIUM BEING RELEASED INTO THE BODY. PFS WAS RECEIVED FROM LEGAL, PRIMARY MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. DOI: (B)(6) 2008 - DOR: NONE REPORTED (LEFT HIP). RECEIPT OF PPF AND STICKER SHEETS.

    Description of Event or Problem · 1

    ADDED STEM DUE TO THE PREVIOUSLY ALLEGED TOXIC LEVELS OF COBALT AND CHROMIUM (K001991/LPH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467253 SUMMIT POR TAPER SZ6 STD OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDIC INC, 1818910 B5TFY1000 10603295059370

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention