BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-STEM AMT SZ3 STD OFFSET

    MDR report key: 3834040 · Received May 27, 2014

    Report

    Report Number
    1818910-2014-19540
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 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
    SF
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. (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

    ASR REVISION; ASR XL - RIGHT; REASON(S) FOR REVISION: UNKNOWN. RESURFACING TO XL PATIENT - THIS IS THE 2ND OF 2 REVISIONS. PLEASE SEE (B)(4) FOR THE 1ST REVISION. INCORRECT, SEE BELOW. CUP IMPLANT DATE: (B)(6) 2006. XL PRODUCTS IMPLANT DATE: (B)(6) 2007. ALL PRODUCTS REVISED: (B)(6) 2013. UPDATE RECEIVED: (B)(4) 2014 - ADVISED PATIENT IS NOT ACTUALLY A RESURFACING TO XL, BUT THE XL IMPLANT WAS COMPLETED IN 2 STAGES-SEE ATTACHED DOCUMENT FOR FURTHER INFORMATION DATES ABOVE ARE CORRECT, ADDED PATIENT GENDER, ADDED PATIENT NAME, ADDED PATIENT INITIALS, ADVISED REVISION MAY HAVE TAKEN PLACE IN NEW ZEALAND, ADVISED REVISION MAY HAVE TAKEN PLACE IN (B)(6) 2013, HAVE KEPT COUNTRY AND REVISION DATE PREVIOUSLY PROVIDED UNTIL CONFIRMATION IS RECEIVED, ADDED STEM AND TAPER SLEEVE LOT NUMBERS AND ADDED PRODUCTS: STEM AND CENTRALIZER FOR STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310624 C-STEM AMT SZ3 STD OFFSET HIP FEMORAL STEM/SLEEVE KXA DEPUY INTERNATIONAL LTD. 8010379 2317855

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention