BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 2880242 · Received December 19, 2012

    Report

    Report Number
    1818910-2012-28673
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 12, 2012
    Report Date
    August 22, 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. (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 ACETABULAR SYSTEM - LEFT; 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 DINT (B)(4) REASON FOR ORIGINAL COMPLAINT - ASR REVISION. ASR XL ACETABULAR SYSTEM - LEFT. REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION. RECEIVED CLINICAL TRIAL DOCUMENT WHICH CONFIRMS THAT IT WAS A CLINICAL TRIAL, REVISION DATE (B)(6) 2012, ADDITIONAL HOSPITAL AND DIFFERENT LOT NO FOR TAPER SLEEVE OF 2642719 NOT 2642718 AS WELL AS SHOWING THAT THE STEM REMAINED IN SITU AND CONFIRMING REVISION TOOK PLACE DO TO MOM REACTION WHICH WAS REPORTED (B)(6) 2008. (B)(4). UPDATE - FILED IN MW FIELDS, AMENDED REVISION DATE, ADDED MANUFACTURING DATES, AMENDED LOT NUMBER FOR SLEEVE. TAKEN FROM CLAIMSUITE DATED 22ND AUGUST 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 2567095

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention