BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40MM M SPEC+5

    MDR report key: 3013522 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-14156
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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. UPDATE - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. A REVIEW OF THE PROVIDED PATIENT RECORDS FINDS A SURGEON STATEMENT THAT THE "APPEARANCE OF THE TISSUES SEEMED TOTALLY CONSISTENT WITH WHAT I HAVE SEEN FOR A METAL ON METAL REACTION." ON THE BASIS OF THIS INFORMATION THE REPORT HAS BEEN CONFIRMED. REVIEW OF THE PATIENT RECORDS HAS NOT IDENTIFIED A NEED FOR CORRECTIVE ACTION. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    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

    UPDATED: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4). NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). (B)(4) FOR ELEVATED METAL IONS.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS HIP PAIN AND METALLOSIS.

    Description of Event or Problem · 1

    PPF ALLEGES ELEVATED METAL IONS. HERE IS NO LAB RESULTS FOR THE ALLEGED ELEVATED METAL IONS IN THE PREVIOUS MEDICAL RECORD

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116772 12/14 ARTICUL 40MM M SPEC+5 FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US 2960853

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention