BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 2925716 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-01038
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 16, 2013
    Report Date
    May 21, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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

    DEPUY STILL 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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Additional Manufacturer Narrative · 1

    DEPUY STILL 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 RESURFACING - RIGHT HIP; REASON(S) FOR REVISION: PAIN; HIGH LEVELS OF CHROMIUM AND COBALT IN THE BLOOD OF THE PATIENT.

    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. HIP(S) TO BE REVISED: RIGHT. TYPE OF HIP REPLACEMENT PRODUCT: ASR RESURFACING. REASON(S) FOR REVISION: PAIN AND HIGH LEVEL OF CRCB IN BLOOD. UPDATE - RECEIVED 17 JAN 2012 - ADDED 2 PRODUCTS AND REVISION COUNTRY - (B)(6). UPDATE- ADDED REVISION COUNTRY TO BOX AND ADDED HOSPITAL TAKEN FROM CLAIMSUITE DATED 30TH JAN 2013. UPDATE- UPDATED REVISION DATE TAKEN FROM CLAIMSUITE DATED 4TH FEB 2013. UPDATE - ADDED SURGEON TAKEN FROM CLAIMSUITE DATED 1ST MARCH 2013. BI-LATERAL PATIENT - PLEASE SEE (B)(4) FOR LEFT SIDE REVISION. UPDATE RECEIVED: 21ST MAY 2014 - LEGAL LETTER, MARKED AS LEGAL, CROSS REFERENCED, ADDED PATIENT NAME, ADDED PATIENT ID (INITIALS), ADDED PATIENT GENDER, ADDED PATIENT DATE OF BIRTH, ADDED HOSPITAL: (B)(6) AND ADDED FURTHER REASON(S) FOR REVISION: INCREASE CADIUM, COBALT, DIFFICULTY WALKING, JOINT PAINS AND CHROMIUM IN BLOOD AND NECROSIS METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30600 TOTAL ASR ACET IMP SIZE 54 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL LTD. 8010379 1239161

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention