BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 50

    MDR report key: 3121664 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-05855
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 5, 2011
    Report Date
    July 28, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PATIENT

    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 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

    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: PAIN, 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: PAIN, ALVAL / SOFT TISSUE REACTION AND COMPONENT LOOSENING. ENQUIRING INTO WHICH COMPONENT BECAME LOOSE. PENDING CONFIRMATION OF: (B)(6) MED DEV SUBMITTED UPDATE: ADDED FURTHER REVISION REASONS AND AMENDED IMPLANT DATE. RECEIVED: MAY 13TH 2013. UPDATE RECEIVED MAY 13TH, 2013. REVISION REASON AMENDED. NO UPDATE - ENTERED IN ERROR (20TH MAY, 2013) COMPONENT LOOSENING IS NOT ONE OF THE REASONS FOR REVISION - PROBABLY INCORRECT INFORMATION. CURRENTLY QUERYING. (20TH MAY, 2013). UPDATE: CLARIFIED REVISION REASONS. RECEIVED: MAY 23RD 2013. REASON(S) FOR REVISION ARE ALVAL / SOFT TISSUE REACTION AND PAIN. PLEASE NOTE THERE ARE 2 SURGEON CONFIRMATION FORMS, THE FIRST WHICH WAS FILLED OUT PRE-REVISION WHERE IT WAS ASSUMED A COMPONENT BECAME LOOSE. AFTER THE REVISION SURGERY HAD TAKEN PLACE IT WAS PROVED THERE WAS NO COMPONENT LOOSENING, ANOTHER SURGEON CONFIRMATION FORM WAS FILLED OUT AFTER REVISION SURGERY IN WHICH THE ACTUAL REASONS FOR REVISION ARE ALVAL / SOFT TISSUE REACTION AND PAIN. UPDATE - MARKED AS LEGAL, ADDED KID NUMBER, TAKEN FROM (B)(6) EMAIL DATED 28TH JULY 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224319 TOTAL ASR ACET IMP SIZE 50 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 2543611

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention