BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL ASR ACET IMP SIZE 52

    MDR report key: 2920780 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-00442
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    April 30, 2011
    Report Date
    August 22, 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
    ATTORNEY

    Narratives

    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

    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.

    Description of Event or Problem · 1

    ASR REVISION; RIGHT HIP; ASR XL SYSTEM; REASON FOR REVISION UNKNOWN.

    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. RIGHT HIP. ASR XL SYSTEM. REASON FOR REVISION UNKNOWN. UPDATE RECEIVED 22ND AUGUST 2014. LOT NUMBER ADDED TO FEMORAL HEAD. ADDITIONAL HOSPITAL ADDED. SURGEON, REVISION REASONS AND STEM ADDED. REVISION DATE AMENDED. REASON(S) FOR REVISION: COMPONENT LOOSENING (STEM AND CUP), PAIN. COMPONENT LOOSENING CONFIRMED 29TH AUGUST 2014. STEM WAS LOOSENED. 01 SEPTEMBER 2014 - SOME PATIENT DEMOGRAPHICS INFORMATION RECEIVED. OPERATIVE NOTES FOR THE REVISION, PATIENT AGE AND SEX ADDED. ADDITIONAL REASONS FOR REVISION ADDED. REASON(S) FOR REVISION: COMPONENT LOOSENING (STEM AND CUP), PAIN, METALLOSIS AND SYNOVIAL FLUID. UPDATE RECEIVED 9TH SEPTEMBER 2014. HCP HAS CONFIRMED THAT THE CUP WAS LOOSENED AS WELL AS THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25905 TOTAL ASR ACET IMP SIZE 52 HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. 8010379 1195502

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention