BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 32IDX50OD

    MDR report key: 2913708 · Received January 14, 2013

    Report

    Report Number
    1818910-2013-10915
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK102423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 WI-7915 APPENDIX A; REV. C. 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

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UPDATE: THE EXPLANTED FEMORAL HEAD AND LINER HAVE BEEN RETURNED FOR EXAMINATION. VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. IT IS SUSPECTED THAT THE DEVICES WERE NOT FULLY ENGAGED WHEN FIRST IMPLANTED, LATER LEADING TO THE DISASSOCIATION NOW REPORTED. DEVICE AND RECORDS EVALUATION DID NOT IDENTIFY OR VERIFY PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. THROUGH PRODUCT TRENDING, THE OCCURRENCE RATE FOR THIS TYPE OF FAILURE IS KNOWN TO BE VERY SMALL. BASED ON THE INVESTIGATION, PRODUCT CONTRIBUTION WAS NOT IDENTIFIED AND A NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS POLY WEAR AND DISASSOCIATION OF THE LINER FROM THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19686 ALTRX NEUT 32IDX50OD ACETABULAR LINER LPH DEPUY ORTHOPAEDICS, INC. 295023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention