BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 3132662 · Received May 29, 2013

    Report

    Report Number
    1818910-2013-06215
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 28, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    Product Code
    KWA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE 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 CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL - RIGHT, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION.

    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 - RIGHT. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. BILATERAL: SEE (B)(4) FOR LEFT HIP REVISION. UPDATE: CORRECTED ALERT DATE TO 24 MAY 2013. UPDATE RECEIVED JUNE 21ST, 2013. HOSPITAL ADDED. UPDATE RECEIVED AUGUST 15TH, 2013. FULL INFORMATION RECEIVED AUGUST 19TH. REVISION AND IMPLANT DATE AMENDED. UPDATE RECEIVED AUGUST 19TH CONFIRMATION RECEIVED 21ST AUGUST, 2013. IMPLANT DATE AMENDED. UPDATE RECEIVED: 28TH MAY 2014 - AMENDED IMPLANT DATE: (B)(6) 2006, AMENDED REVISION DATE: (B)(6) 2013 AND FILLED MAPPED TO MW FIELDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235460 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2122155

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention