BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 10D 36IDX54OD

    MDR report key: 3802675 · Received May 9, 2014

    Report

    Report Number
    1818910-2014-18440
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 13, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK062148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    THE PATIENT WAS REVISED TO ADDRESS A DRAINING AND APPARENT INFECTED THA. DURING REMOVAL OF THE FEMORAL HEAD THE TITANIUM SLEEVE DISASSOCIATED FROM THE HEAD. UPON REVISION THERE WAS NO GROSS PURULENCE NOTED, BUT THE LINER AND HEAD WERE EXCHANGED. (B)(4). 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. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. MEDICAL RECORDS AND X-RAYS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. WITH THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED 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

    THE PATIENT WAS REVISED TO ADDRESS A DRAINING AND APPARENT INFECTED THA. DURING REMOVAL OF THE FEMORAL HEAD THE TITANIUM SLEEVE DISASSOCIATED FROM THE HEAD. UPON REVISION THERE WAS NO GROSS PURULENCE NOTED, BUT THE LINER AND HEAD WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280630 ALTRX +4 10D 36IDX54OD HIP ACETABULAR INSERT/LINER LPH DEPUY ORTHOPAEDICS, INC. 1818910 480319

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention