BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 56

    MDR report key: 2992807 · Received March 7, 2013

    Report

    Report Number
    1818910-2013-03271
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    October 8, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    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

    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.

    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.

    Additional Manufacturer Narrative · 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. ON 08 OCT 2015 - UPDATE - RCVD AMENDED IMPLANT DATE - COMF BY EMAIL 21 OCT 2015 THAT CORRECT IMPLANT DATE IS (B)(6) 2007. STEM DETAILS ARE UNAVAILABLE. PATIENT IS BILATERAL - FOR RIGHT HIP SEE (B)(4) - (B)(6) 2015. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL ACETABULAR SYSTEM - LEFT HIP; REASON FOR REVISION: ALVAL/SOFT TISSUE REACTION.

    Description of Event or Problem · 1

    08 OCT 2015 - UPDATE - RCVD AMENDED IMPLANT DATE - COMF BY EMAIL (B)(6) 2015 THAT CORRECT IMPLANT DATE IS (B)(6) 2007. STEM DETAILS ARE UNAVAILABLE. PATIENT IS BILATERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96844 TOTAL ASR ACET IMP SIZE 56 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1824314

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention