BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPER SLEEVE ADAPTER 12/14 +2

    MDR report key: 3863114 · Received June 10, 2014

    Report

    Report Number
    1818910-2014-20540
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    August 4, 2010
    Report Date
    March 4, 2015
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWY
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. (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. (B)(4). DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    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.

    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; LEFT; ASR XL; REASON(S) FOR REVISION: PAIN / NOISE. UPDATE RECEIVED: 10TH JUNE 2014 - AMENDED IMPLANT DATE: (B)(6) 2006.

    Description of Event or Problem · 1

    ASR REVISION; LEFT; ASR XL; REASON(S) FOR REVISION: PAIN / NOISE.

    Description of Event or Problem · 1

    ASR REVISION, LEFT, ASR XL. REASON(S) FOR REVISION: PAIN / NOISE. UPDATE RECEIVED: 10TH JUNE 2014 - AMENDED IMPLANT DATE: (B)(6) 2006. UPDATE 19 FEB 2015 - CORRECTED THE IMPLANT DATE BACK TO (B)(6) 2007 AS THE CHANGE TO (B)(6) 2006 IS NOT POSSIBLE AS IT IS BEFORE THE MANUFACTURING DATE OF THE PRODUCTS. (B)(4).

    Description of Event or Problem · 1

    ASR REVISION, LEFT, ASR XL, REASON(S) FOR REVISION: PAIN / NOISE. UPDATE RECEIVED: (B)(6) 2014 - AMENDED IMPLANT DATE: (B)(6) 2006. UPDATE - (B)(6) 2015 - CORRECTED THE IMPLANT DATE BACK TO (B)(6) 2007 AS THE CHANGE TO (B)(6) 2006 IS NOT POSSIBLE AS IT IS BEFORE THE MANUFACTURING DATE OF THE PRODUCTS. ((B)(4)). UPDATE - ADDED ALL EXPIRY DATES, PREVIOUSLY MISSED. ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340546 TAPER SLEEVE ADAPTER 12/14 +2 HIP FEMORAL STEM/SLEEVE KWY DEPUY INTERNATIONAL LTD. 8010379 2177800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention