BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 47

    MDR report key: 3191718 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19961
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    April 21, 2011
    Report Date
    March 28, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD.
    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    REASON FOR REVISION: PAIN.

    Description of Event or Problem · 1

    ASR REVISION. ASR HIP RESURFACING SYSTEM - RIGHT. REASON FOR REVISION - UNKNOWN. UPDATE RECEIVED (B)(4) 2013. REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED (B)(4) 2014: SURGERY DATE AMENDED. LOT NUMBER REMOVED FOR FEMORAL HEAD AS INVALID : 2558669. BILATERAL PATIENT - SEE (B)(4) FOR LEFT HIP.

    Description of Event or Problem · 1

    ASR REVISION, ASR HIP RESURFACING SYSTEM - RIGHT, REASON FOR REVISION - UNKNOWN KID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290411 TOTAL ASR FEM IMP SIZE 47 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention