BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2874545 · Received December 14, 2012

    Report

    Report Number
    1818910-2012-28731
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    April 3, 2017
    Report Date
    August 15, 2012
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    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.

    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.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED SEVERE PAIN, DISABILITY, PHYSICAL IMPAIRMENT, DISFIGUREMENT, AGGRAVATION OF A PRE-EXISTING CONDITION AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Description of Event or Problem · 1

    UPDATE AD 3 MAY 2018: ASR MEDICAL RECORDS AND STICKER SHEET RECEIVED. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS FAILED LEFT HIP REPLACEMENT RELATED TO METALLOSIS. OPERATIVE NOTES STATED THAT THERE WAS A SIGNIFICANT METALLOSIS CHANGES INSIDE THE ACETABULUM AFFECTING THE BURSAL TISSUE DOWN TO THE SYNOVIAL LINING. ADDED COMPLAINT INFORMATION. DOI: (B)(6) 2009; DOR: (B)(6) 2017; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL LTD. 8010379 2833740

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other