BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 3010473 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-04123
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 3, 2014
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 THIS INVESTIGATON CLOSED.

    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.

    Description of Event or Problem · 1

    UPDATE - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THERE WAS EXCESSIVE DEBRIS FILLED FLUID, BROWNISH, DARKISH DISCOLORATION OF THE INNER CAPSULE WITH THE PRESENCE OF A PSEUDOMEMBRANE. FEMORAL HEAD ADDED TO COMPLAINT.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO CUP LOOSENING. (UNKNOWN HIP).

    Description of Event or Problem · 1

    **UPDATE** (B)(4) 2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN AND ELEVATED METAL ION LEVELS. HIP SIDE PROVIDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2013 COMMENT: THERE IS A DOI DISCREPANCY BETWEEN LITIGATION AND WHAT WAS PREVIOUSLY REPORTED ON THE DER. DUE TO ACCURACY, THE DOI FROM THE DER WILL REMAIN. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE IF NEEDED.

    Description of Event or Problem · 1

    UPDATE 03/03/2014 - PLAINTIFF'S FACT SHEET WAS RECEIVED, WHICH IDENTIFIED DOI INFORMATION ON STICKER SHEET. PART/LOT WAS ALSO PROVIDED. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. COMPLAINT WAS UPDATED ON 03/12/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113676 ASR ACETABULAR CUPS 48 ACETABULAR CUP KWA DEPUY INTERNATIONAL 2612441

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention