BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 51

    MDR report key: 2911562 · Received January 11, 2013

    Report

    Report Number
    1818910-2013-00199
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 27, 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
    US
    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.

    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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - ASR REVISION, ASR HIP RESURFACING SYSTEM - LEFT, REASON(S) FOR REVISION: PAIN. UPDATE 31 OCT 2014. (B)(6) ALERT RECEIVED. MARKED AS LEGAL. (B)(6) ALERT SHOWS TWO REVISION DATES. QUERY HAS BEEN SENT.

    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. ASR HIP RESURFACING SYSTEM - LEFT. REASON(S) FOR REVISION: PAIN. **UPDATE** 31 OCT 2014. KENNEDYS ALERT RECEIVED. MARKED AS LEGAL. KENNEDYS ALERT SHOWS TWO REVISION DATES. QUERY HAS BEEN SENT. **UPDATE** 27 NOV 2014. KENNEDYS UPDATE RECEIVED. CORRECTED DOR.

    Description of Event or Problem · 1

    ASR REVISION; ASR HIP RESURFACING SYSTEM - LEFT HIP; REASON FOR REVISION: PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16285 TOTAL ASR FEM IMP SIZE 51 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2250250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention