BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARGE MOD HEAD ADAPT 12/14 +5

    MDR report key: 4090629 · Received September 15, 2014

    Report

    Report Number
    1818910-2014-28031
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    July 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    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. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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.

    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 DUE TO TAKE PLACE (B)(6) 2014; ASR XL - RIGHT; REASON(S) FOR REVISION: PAIN. UPDATE - ADDED A SLEEVE. TAKEN FROM (B)(4) DATED (B)(4) 2014. UPDATE - ADDED STEM. TAKEN FROM (B)(4) DATED (B)(4) 2014. UPDATE - AMENDED REVISION DATE, TAKEN FROM (B)(4) DATED (B)(4) 2014.

    Description of Event or Problem · 1

    ASR REVISION DUE TO TAKE PLACE (B)(6) 2014. ASR XL - RIGHT. REASON(S) FOR REVISION: PAIN. UPDATE - ADDED A SLEEVE. TAKEN FROM CLAIMSUITE DATED 11TH JULY 2014. UPDATE - ADDED STEM. TAKEN FROM CLAIMSUITE DATED 25TH JULY 2014. UPDATE - AMENDED REVISION DATE, TAKEN FROM CLAIMSUITE DATED 22ND AUG 2014. UPDATE - ADDED PATIENT NAME, ADDITIONAL HOSPITAL, ADDITIONAL REASONS FOR REVISION. TAKEN FROM SURGEON FORM DATED (B)(6) 2014. REASON (S) FOR REVISION : NOISE, RAISED COBALT AND CHROMIUM BLOOD LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570414 LARGE MOD HEAD ADAPT 12/14 +5 HIP FEMORAL STEM/SLEEVE KXA DEPUY INTERNATIONAL LTD. 8010379 2381913

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention