BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMA HI OFFSET R SZ 4

    MDR report key: 3140241 · Received May 31, 2013

    Report

    Report Number
    1818910-2013-06329
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 26, 2013
    Report Date
    September 1, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(6) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON THE HIP IMPLANT. THE REASON FOR THE REVISION IS UNKNOWN.

    Description of Event or Problem · 1

    UPDATE 3 SEPTEMBER 2015: UPDATED HIP SIDE TO RIGHT HIP. UPDATED TO LEGAL AND ATTACHED LEGAL CLAIM. UPDATED REASONS FOR REVISION TO INCLUDE IMPLANT NOISE (SQUEAK), ELEVATED COBALT & CHROMIUM LEVELS & METALLOSIS. ADDED PATIENT'S NAME AND DATE OF BIRTH, UPDATED GENDER. ADDED PRIMARY SURGERY HOSPITAL. ADDED KENNEDYS DETAILS AS COMPLAINANT. ADDED MANUFACTURE AND EXPIRY DATES FOR PRODUCTS. TAKEN FROM NEW ASR LEGAL CLAIM 2 SEPTEMBER 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241273 PROXIMA HI OFFSET R SZ 4 HIP FEMORAL STEM/SLEEVE LPH DEPUY INTERNATIONAL LTD - 8010379 2034798

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention