BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2773724 · Received October 5, 2012

    Report

    Report Number
    1818910-2012-16837
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    March 7, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 1818910-2016-19229. THIS REPORT, 1818910-2012-16837, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2016-19229. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. 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

    BILATERAL PATIENT: LITIGATION PAPERS ALLEGE PAIN, LOSS OF MOBILITY AND LOSS OF ENJOYMENT OF LIFE. UPDATE: (B)(6) 2012 PLAINTIFF FACT SHEET RECEIVED WITH PART/LOT INFORMATION.

    Description of Event or Problem · 1

    UPDATE 03/02/2016 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. MEDICAL RECORDS REPORTED PATIENT TO BE REVISED ON (B)(6) 2015 FOR METALLOSIS AND PAIN WITH A MODERATE AMOUNT OF SLIGHTLY CLOUDY JOINT FLUID AND METALLIC STAINING OF THE SYNOVIAL LAYER. DOR WILL BE UPDATED AND AN UNKNOWN TAPER SLEEVE WILL BE ADDED TO THE COMPLAINT FOR PAIN AND METALLOSIS. THE COMPLAINT WAS UPDATED ON: MAR 22, 2016.

    Description of Event or Problem · 1

    SUPPLEMENTAL INFORMATION RECEIVED. LITIGATION ALLEGES THAT THE PATIENT UNDERWENT A REVISION TO ADDRESS PAIN AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2946157

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR