BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 2011288 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03028
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    January 21, 2010
    Report Date
    August 12, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    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).

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE 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

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

    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 CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR XL ACETABULAR SYSTEM (RIGHT), SEE UPDATE BELOW - NOW LEFT. REASON(S) FOR REVISION: UNKNOWN. UPDATED: ADDED AND AMENDED PRODUCTS. RECEIVED: 11TH OCTOBER 2012. HIP(S) TO BE REVISED: LEFT. UPDATE : REVISED HIP AMENDED AS PER UPDATE EMAIL 13 DEC 2012. UPDATE RECEIVED: 11TH OCTOBER 2013 - AMENDED REVISION DATE: (B)(6) 2010. UPDATE RECEIVED: 12TH AUGUST 2014 - ADDED REASON(S) FOR REVISION: INFECTION (TESTED AND POSITIVE CULTURE CONFIRMED) AND ALVAL / SOFT TISSUE REACTION AND FILLED MAPPED TO MW FIELDS.

    Description of Event or Problem · 1

    THE PATIENT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REPORT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. NA 2368865

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention