BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3191557 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19944
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 21, 2013
    Report Date
    February 24, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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

    DEPUY STILL 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

    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

    PATIENT UNDERWENT REVISION PROCEDURE OF LEFT HIP DUE TO PAIN AND OSTEOLYSIS. **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. MEDICAL RECORDS AND REVISION OPERATIVE REPORT INDICATE THE FOLLOWING: PAIN; SWELLING; FLUID COLLECTION; EXCISION OF PSEUDOTUMOR RESULTED IN COMPLETE POSTERIOR CAPSULE; ADVERSE LOCAL TISSUE REACTION; ANTERIOR CAPSULE ALSO REMOVED WHICH WAS QUITE THICK.

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES ELEVATED METAL ION LEVELS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2013.

    Description of Event or Problem · 1

    UPDATE (B)(4) 2014 - PLAINTIFF FACT SHEET WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT REVISION PROCEDURE OF LEFT HIP DUE TO PAIN AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290349 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD KWA DEPUY INTL., LTD. - 8010379 2870840

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention