BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 3073415 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-04867
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    January 10, 2014
    Report Date
    March 28, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED 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.

    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.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2014 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PATIENT HAD PAIN, DISABILITY AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT AFTER ASR HIP IMPLANT.

    Description of Event or Problem · 1

    UPDATE: 03/28/2014 - MEDICAL RECORDS RECEIVED. PATIENT WAS REVISED TO ADDRESS LIGHT YELLOW, THICK FLUID, AND BONE LOSS. THE INFORMATION RECEIVED DOES NOT CHANGE THE MDR DECISION. THIS COMPLAINT WAS UPDATED ON: 04/13/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175619 ASR ACETABULAR CUPS 52 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2940017

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other