BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3034062 · Received April 3, 2013

    Report

    Report Number
    1818910-2013-01675
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    June 5, 2018
    Report Date
    May 31, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: 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. THE INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS WAS CONDUCTED UNDER MDD CAPA (B)(4). ONGOING POST MARKET SURVEILLANCE IS CONDUCTED PER OUR PROCEDURES FOR THIS PRODUCT 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 PAPERS ALLEGE ON OUR ABOUT (B)(6), 2010, PATIENT BEGAN TO SUFFER SEVERE HIP, THIGH AND GROIN PAIN, AUDIBLE POPPING WHILE WALKING, SEVERE PAIN WHILE WALKING; SEVERE PAIN WHILE SITTING; GREAT DISCOMFORT AND DISTRESS IN PERFORMING HER DAY TO DAY ACTIVITIES; INCURRED AND MAY CONTINUE TO INCUR IN THE FUTURE, AND REASONABLE MEDICAL AND OTHER EXPENSES FOR NECESSARY MEDICAL TREATMENT; AND, MISSED TIME FROM WORK RESULTING IN LOST WAGES.

    Description of Event or Problem · 1

    DER RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, DER STATES THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. ASR CUP REMOVED AND REPLACED WITH PINNACLE GRIPTION SECTOR. SROM STEM REMOVED FOR EXPOSURE TO ACETABULUM AND REPLACED WITH NEW. CORRECTED PATIENT'S INITIAL AND ADDED DOR AND PATIENT'S AGE. DOI: (B)(6) 2006; DOR: (B)(6) 2018; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135692 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL LTD. 8010379 2179472

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other