BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 62

    MDR report key: 2232827 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-15695
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 23, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    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).

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. 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

    THE PATIENT WAS REVISED TO ADDRESS ALVAL.

    Description of Event or Problem · 1

    NEW (B)(6) RECORD CREATED IN ORDER TO UPDATE (B)(6) (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4) REASON FOR ORIGINAL COMPLAINT - ASR REVISION - BI-LATERAL. ONLY ONE HIP IS DEPUY, OTHER HIP UNKNOWN. ALVAL / SOFT TISSUE REACTION. UPDATE: ADDITIONAL PRODUCTS RECEIVED FROM (B)(6) 14 FEB 2012. UPDATE - ADDED CORRECT HIP SIDE, AND ADDITIONAL REASON FOR REVISION AND DETAILS ABOUT THE STEM. TAKEN FROM EMAIL DATED 23RD MAY 2014. RIGHT. REASON FOR REVISION : ELEVATED IONS, ARMD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 62 87KWA KWA DEPUY INTERNATIONAL LTD. 8010379 NA 2233404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention