BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 2954246 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-01957
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 18, 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

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - RIGHT HIP; REASON(S) FOR REVISION: TRAUMA; SEVERE OSTEOLYSIS OF ACETABULUM.

    Description of Event or Problem · 1

    7 OCT 2015 - UPDATE - RCVD UPDATED IMPLANT DATE. CONF NO STEM DETAILS AVAILABLE.

    Description of Event or Problem · 1

    ADDED ADDITIONAL REASON FOR REVISION. TAKEN FROM CLAIMSUITE DATED (B)(6) 2015 . REASON(S) FOR REVISION: COMPONENT LOOSENING ASR CUP.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - RIGHT HIP; REASON FOR REVISION: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58087 TOTAL ASR ACET IMP SIZE 54 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379 2417412

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention