BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR FEM IMP SIZE 47

    MDR report key: 2972006 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-02594
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    June 28, 2017
    Report Date
    March 26, 2013
    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

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    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.

    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.

    Additional Manufacturer Narrative · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGAL SYSTEM) COMPLAINT NUMBER DINT 26488 . REASON FOR ORIGINAL COMPLAINT ¿ ASR REVISION ASR RESURFACING - LEFT REASON(S) FOR REVISION: PAIN, COMPONENT LOOSENING - SOCKET OR ACETABULAR COMPONENT WAS LOOSE CERTAINLY NOT WELL FIXED AND INCREASED METAL IONS. PAIN, IRRITABLE HIP, RESTRICTED RANGE OF MOTION. IRELAND REFERENCE NUMBER: ASR-NI-20,278 UPDATE: ADDED FURTHER REVISION REASONS AND AMENDED REVISION DATE. RECEIVED: FEBRUARY 22ND 2013. UPDATE: AMENDED IMPLANT DATE AND ADDED FURTHER REVISION REASON. RECEIVED: MARCH 27TH 2013. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ASR REVISION; ASR RESURFACING - LEFT HIP; REASON(S) FOR REVISION: PAIN COMPONENT LOOSENING; INCREASED METAL IONS.

    Description of Event or Problem · 1

    ASR REVISION; ASR RESURFACING - LEFT HIP; REASON(S) FOR REVISION: PAIN; COMPONENT LOOSENING - SOCKET OR ACETABULAR COMPONENT (CERTAINLY NOT WELL FIXED); INCREASED METAL IONS; IRRITABLE HIP; RESTRICTED RANGE OF MOTION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76608 TOTAL ASR FEM IMP SIZE 47 HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 2499235

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention