BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 53

    MDR report key: 3121191 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-05417
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    November 8, 2010
    Report Date
    September 5, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    UPDATE: MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT FOR THE RIGHT HIP INDICATES THE FOLLOWING: LOOSE CUP; PAIN; SMALL AMOUNT OF FLUID BUT NO EVIDENCE OF METALLIC FRAGMENTS. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE BILATERAL PATIENT WAS REVISED ON THE RIGHT SIDE TO ADDRESS LOOSENING OF THE CUP. UPDATE: (B)(4) 2011 - MEDICAL RECORDS RECEIVED. ORIGINAL SURGERY DATES AND PRODUCT/LOT CODES IDENTIFIED. UPDATE: (B)(4) 2012 PLAINTIFFS FACT SHEET (PFS) RECEIVED (B)(4) 2012. ADDED RIGHT FEMORAL HEAD PRODUCT TO COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222840 ASR UNI FEMORAL IMPL SIZE 53 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2628742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention