BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 3141139 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-17994
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE INVESTIGATION CLOSED.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 PATIENT HAD PAIN AND HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN HER BLOOD.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT HAD PAIN AND HIGH CONCENTRATIONS OF VARIOUS METALLIC ELEMENTS IN HER BLOOD.UPDATE RECEIVED 17TH APRIL 2014. SURGEON, PATIENT AGE, HOSPITALS, PRODUCTS, REVISION REASON ADDED. NEW FIELDS COMPLETED.HIP SIDE: LEFT.REASON FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243215 ASR ACETABULAR CUPS 52 HIP ACETABULAR CUP KWA DEPUY INTL., LTD. - 8010379 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other| R