BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 14B-SML

    MDR report key: 4233801 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31338
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    November 18, 2013
    Report Date
    October 31, 2014
    Manufacturer
    DEPUY IRELAND
    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. WWCAPA (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.

    Description of Event or Problem · 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 (LEFT), REASON(S) FOR REVISION: PAIN. NO LOT NUMBER PROVIDED FOR SLEEVE. UPDATE- ADDED LOT NUMBERS TO CUP HEAD AND SLEEVE AND ADDED A STEM AND STEM-SLEEVE. TAKEN FROM CLAIMSUITE DATED (B)(6) 2012 . UPDATE - (B)(6) 2014. SCF AND UPDATED CLAIMSUITE RECEIVED. ADDED NOISE / ALVAL / SOFT TISSUE REACTION AND LOOSENING (UNKNOWN COMPONENT - REPORTING ALL AS LOOSE UNTIL CONFIRMATION RECEIVED) AS REASONS FOR REVISION. ADDED (B)(6) AS AN ADDITIONAL SURGEON AND UPDATED DOI AND DOR TO (B)(6) 2006 AND (B)(6) 2013 RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715267 S-ROM*SLEEVE PRX ZTT, 14B-SML HIP FEMORAL STEM/SLEEVE KXA DEPUY IRELAND 1084849

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention