BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 32IDX52OD

    MDR report key: 2920047 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-11114
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    June 27, 2006
    Report Date
    December 20, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. MEDICAL RECORDS RECEIVED FROM LEGAL, THE PATIENT WAS REVISED BECAUSE OF PAIN, POLY WEAR WITH A FRACTURED LINER. THIS WAS NOT PART OF THE LITIGATION. DOI: (B)(6) 2004, DOR: (B)(6) 2006 (LEFT HIP). THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. THE PATIENT IS A REPORTED FEMALE WITH A CALCULATED BMI OF (B)(6). THE PATIENT IS CONSIDERED MORBIDLY OBESE. IT IS STATED IN THE WARNINGS AND PRECAUTIONS THAT EXCESSIVE PATIENT WEIGHT TENDS TO ADVERSELY AFFECT HIP REPLACEMENT IMPLANTS. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED FROM LEGAL, THE PATIENT WAS REVISED BECAUSE OF PAIN, POLY WEAR WITH A FRACTURED LINER. THIS WAS NOT PART OF THE LITIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26153 PINN MAR +4 10D 32IDX52OD HIP LINER LPH DEPUY ORTHOPAEDICS, INC. XR9H81014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention