BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 60

    MDR report key: 2213233 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15031
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 25, 2014
    Report Date
    November 18, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. (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.

    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

    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

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

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PT WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    UPDATE REC 11/18/2014 -MEDICAL RECORDS RECEIVED. UPON REVISION, FLUID, ADVERSE LOCAL SOFT TISSUE REACTION, AND NO BONY INGROWTH ON THE ACETABULAR CUP WERE NOTED. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT FOR ELEVATED METAL ION LEVELS. THE STEM REMAINED IN SITU. THIS COMPLAINT WAS UPDATED ON: 12/18/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 06/25/2014 - SALES REP REPORTED REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN. THE PATIENT PREVIOUSLY HAD A RESURFACING HEAD, WHICH WAS REVISED ON (B)(6) 2009. INFORMATION FOR THE RESURFACING HEAD CAN BE LOCATED ON (B)(4). THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 07/17/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 60 ACETABULAR SHELL KWA DEPUY INTERNATIONAL, LTD. NA 2324505

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention