BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM HEAD FEMORAL COCR 32+3

    MDR report key: 3031086 · Received April 2, 2013

    Report

    Report Number
    1818910-2013-14779
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    July 7, 2010
    Report Date
    March 5, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDG
    PMA / PMN Number
    K920317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. UPDATE: LEGAL CLAIM AND MEDICAL RECORDS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, NUMBNESS, LIMITED MOBILITY, AND STEM LOOSENING. DOI: (B)(6) 2007- DOR: (B)(6) 2010 (RIGHT HIP). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. MEDICAL RECORDS WERE REVIEWED BY THE DEPUY LEGAL NURSE WHO FOUND FROM A MEDICAL PERSPECTIVE , BASED ON THE INFORMATION AVAILABLE, IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPDATE REC'D 8/6/2014 - LITIGATION PAPERS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, LITIGATION ALLEGES THE PATIENT SUFFERS FROM DISCOMFORT, AND. INFLAMMATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UPDATE 9/2/15-PFS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON:9/29/2015.

    Description of Event or Problem · 1

    LEGAL CLAIM AND MEDICAL RECORDS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, NUMBNESS, LIMITED MOBILITY, AND STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135201 S-ROM HEAD FEMORAL COCR 32+3 FEMORAL HEAD JDG DEPUY INTERNATIONAL LTD - 8010379 2324992

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention