BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM M HEAD 36MM +3

    MDR report key: 3849598 · Received June 4, 2014

    Report

    Report Number
    1818910-2014-20152
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    May 10, 2014
    Report Date
    June 6, 2014
    Manufacturer
    DEPUY INTL., LTD. 8010379
    Product Code
    LPH
    PMA / PMN Number
    PK851422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS PAIN. CLINICAL REPORT WAS ALSO RECEIVED. CLINICAL REPORT STATES THAT THE PATIENT WAS REVISED TO ADDRESS ADVERSE LOCAL TISSUE REACTION. UPDATE REC¿D 06/06/2014- THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS STATE THE PATIENT HAD INCREASED ION LEVELS. THEY ALSO INDICATE UPON REVISION A MODERATE AMOUNT OF TRUNNIONIS WAS FOUND. THE FEMORAL STEM IS BEING ADDED TO THE COMPLAINT AT THIS TIME. (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 2953196 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 2877696 LOT CODE IS NO LONGER REQUIRED PER WI-3430. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF 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 IDENTIFY 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

    PATIENT WAS REVISED TO ADDRESS PAIN. CLINICAL REPORT WAS ALSO RECEIVED. CLINICAL REPORT STATES THAT THE PATIENT WAS REVISED TO ADDRESS ADVERSE LOCAL TISSUE REACTION.

    Description of Event or Problem · 1

    UPDATE REC¿D 06/06/2014- THE PATIENT'S MEDICAL RECORDS WERE RECEIVED. RECORDS STATE THE PATIENT HAD INCREASED ION LEVELS. THEY ALSO INDICATE UPON REVISION A MODERATE AMOUNT OF TRUNNIONIS WAS FOUND. THE FEMORAL STEM IS BEING ADDED TO THE COMPLAINT AT THIS TIME. THE COMPLAINT WAS UPDATED ON: JUL 2, 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326870 S-ROM M HEAD 36MM +3 HIP FEMORAL HEAD LPH DEPUY INTL., LTD. 8010379 2918800

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention