BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 53

    MDR report key: 2881960 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-28683
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    September 6, 2007
    Report Date
    February 20, 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
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED. 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

    THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    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. 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) (B)(4). REASON FOR ORIGINAL COMPLAINT: ASR REVISION, ASR HIP RESURFACING SYSTEM; ASR XL ACETABULAR SYSTEM, REASON(S) FOR REVISION: COMPONENT LOOSENING (HEAD) AND PAIN. PRODUCTS REMAIN: 999805360 ASR ACETABULAR IMPLANT 60 1945512 999890153 DEPUY ASR XL FEM IMP SIZE 53 1180689 999800105 ASR XL TAP SLV ADAP 12/14+5 2427743 PLUS A COMPETITOR STEM. CUP REMAINED IN SITU - RIGHT SIDE HIP. THIS IS THE 1ST REVISION OF 2. PLEASE SEE (B)(4) FOR 2ND REVISION. REPLACEMENT OF THE ASR. NECROSIS OF HEAD FEMUR. UPDATE RECEIVED: 20TH FEBRUARY 2014 - CLARIFIED DETAILS OF DUPLICATE DINT, ADDED ANY EXTRA ATTACHMENTS AND INFORMATION: PATIENT AGE, SEX AND DATE OF BIRTH AND HOSPITAL: FROM DUPLICATE DINT, ADDED (B)(6) REFERENCE NUMBER, CROSS REFERENCED AND MARKED AS LEGAL. (B)(6).

    Description of Event or Problem · 1

    ASR REVISION: ASR HIP RESURFACING SYSTEM; ASR XL ACETABULAR SYSTEM. REASON(S) FOR REVISION: COMPONENT LOOSENING (HEAD) AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR FEM IMP SIZE 53 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD - 8010379 1958613

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention