BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE MOD HEAD ADAPT 12/14 +5

    MDR report key: 2801378 · Received October 23, 2012

    Report

    Report Number
    1818910-2012-77035
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    August 29, 2012
    Report Date
    June 19, 2015
    Manufacturer
    DEPUY INTL., LTD. - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. (B)(4).

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT; REASON FOR REVISION: UNKNOWN.

    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 TO TAKE PLACE ON (B)(6) 2012, ASR XL - LEFT, REASON(S) FOR REVISION: UNKNOWN. BI-LATERAL - SEE (B)(4) FOR RIGHT HIP. UPDATE: ADDED PRODUCT AND DATE OF REVISION. RECEIVED: (B)(6) 2012. (B)(6) 2015 - UPDATE - RCVD REASON FOR REVISION: ALVAL / SOFT TISSUE REACTION, STATES NO CODES AVAILABLE FOR STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE KWA DEPUY INTL., LTD. - 8010379 1201135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention