BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 56

    MDR report key: 3010147 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-04308
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 24, 2014
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 INVESTIGATION CLOSED. THIS IS A DUPLICATE REPORT OF 1818910-2014-17850. THIS REPORT, 1818910-2013-04308, WILL BE KEPT FOR INVESTIGATION PURPOSES. A SEPARATE FOLLOW-UP REPORT WILL BE SUBMITTED TO REJECT 1818910-2014-17850.

    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 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.

    Description of Event or Problem · 1

    UPDATE REC'D 04/24/2014 - LITIGATION ALLEGES PAIN, GRINDING AND POPPING NOISES, DISCOMFORT, ELEVATED METAL ION LEVELS, AND FLUID COLLECTION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 05/19/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 04/24/2014 - LITIGATION ALLEGES PAIN, GRINDING AND POPPING NOISES, DISCOMFORT, ELEVATED METAL ION LEVELS, AND FLUID COLLECTION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.THE COMPLAINT WAS UPDATED ON: 05/19/2014.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO PAIN AND ELEVATED COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113730 ASR ACETABULAR CUPS 56 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2081402

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention