BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 3800963 · Received May 8, 2014

    Report

    Report Number
    1818910-2014-18397
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 22, 2014
    Report Date
    August 15, 2014
    Manufacturer
    DEPUY INTERNATIONAL 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
    CA, 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. (B)(4). DEPUY CONSIDERS THIS 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.

    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.(B)(4). 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

    DECONTAMINATION REPORT AND LEGAL CLAIM RECEIVED. NO REASON FOR REVISION PROVIDED. UPDATE REC'D (B)(4) 2014: SALES REP REPORTED REVISION SURGERY. PATIENT REVISED TO ADDRESS PAIN AND PSEUDOTUMOR. DOR INCORRECTLY STATED AS (B)(4) /2014 AND A FOLLOW-UP REQUEST HAS BEEN SENT FOR CLARIFICATION FROM THE SALES REP. PREVIOUSLY REPORTED DOR FROM LEGAL CLAIM AND DECONTAMINATION REPORT BEING REPORTED. SHOULD WE RECEIVE ADDITIONAL INFORMATION, WE WILL UPDATE IF NEEDED.

    Description of Event or Problem · 1

    UPDATE REC¿D 06/03/2014 - LEGAL CLAIM WAS RECEIVED, WHICH IDENTIFIED DOI INFORMATION. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 06/24/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 5/15/2014 - UPDATE RECEIVED FROM SALES REP. DOR UPDATED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THIS COMPLAINT WAS UPDATED ON: 05/27/2014.

    Description of Event or Problem · 1

    UPDATE REC'D 08/15/2014 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES LOOSENED ACETABULAR CUP, METALLIC DEBRIS, AND ELEVATED METAL IONS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 09/02/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277183 ASR ACETABULAR CUPS 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD.-8010379 2431914

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention