BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR LIP LNR 32IDX60OD

    MDR report key: 3072940 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15766
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD TO SUGGEST PRODUCT ERROR. A WORLDWIDE COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A; REV. D. TWO PATIENT X-RAYS, ONE OF POOR QUALITY, WERE PROVIDED FOR EXAMINATION. PER EXAMINATION BY DEPUY ENGINEERING: NO DEDUCTIONS CAN BE MADE FROM THE PROVIDED X-RAYS. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS AN UNDERSIZED, LOOSE STEM. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173276 PINN MAR LIP LNR 32IDX60OD ACETABULAR LINER LPH 1818910 DEPUY ORTHOPAEDICS, INC. A1YC91

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention