BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 32IDX48OD

    MDR report key: 3012284 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-14116
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    PK102423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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. PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY, AND DISASSOCIATION. DOI (B)(6) 2011 - DOR (B)(6) 2013 (LEFT HIP). UPDATE (B)(4) 2013 - PATIENT'S MEDICAL RECORDS AND X-RAYS WERE RECEIVED. NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. UPDATING LOT NUMBER FOR THE ACETABULAR CUP. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. X-RAYS AND MEDICAL RECORDS WERE OBTAINED AND REVIEWED. WITH THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THE COMPLAINT IS PRODUCT RELATED. IT IS NOTED THAT THE PATIENT IS CONSIDERED OBESE AND HAS NOT FOLLOWED SURGEON PRECAUTIONS. 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.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY, AND DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115022 ALTRX NEUT 32IDX48OD ACETABULAR LINER LPH DEPUY ORTHOPAEDICS, INC. 1818910 FG2G21

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention