BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*HEAD FEMORAL COCR 32+0

    MDR report key: 2881750 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-84006
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    April 5, 2012
    Report Date
    November 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K920317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    (B)(4). ADDED: (PATIENT,DEVICE).

    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. MEDICAL RECORDS WERE RECEIVED FROM LEGAL. UPON REVIEW IT WAS NOTED THAT THE PATIENT WAS REVISED ON (B)(6) 2012 DUE TO DISLOCATION. ADDITIONAL MEDICAL RECORDS ARE AVAILABLE ON DISC IF NEED FOR FURTHER REVIEW. DOI: (B)(6) 2012 - DOR: (B)(6) 2012 (RIGHT HIP). 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. A REVIEW OF PROVIDED PATIENT RECORDS HAS NOT IDENTIFIED A ROOT CAUSE. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    MEDICAL RECORDS WERE RECEIVED FROM LEGAL. UPON REVIEW IT WAS NOTED THAT THE PATIENT WAS REVISED ON 04/05/2012 DUE TO DISLOCATION. ADDITIONAL MEDICAL RECORDS ARE AVAILABLE ON DISC IF NEED FOR FURTHER REVIEW.

    Description of Event or Problem · 1

    IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL ION. ADDED PATIENT'S SEX, REVISION HOSPITAL, REVISION SURGEON AND LAWYER IN THE ASSOCIATED CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM*HEAD FEMORAL COCR 32+0 S-ROM FEMORAL HEADS (11/13) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 3333271

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention