BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 36IDX52OD

    MDR report key: 3023517 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-14544
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK072963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICES WERE EVALUATED BY A DEPUY MATERIAL SCIENTIST. NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS WAS OBSERVED. A PREVIOUS REVIEW OF THE HOLE ELIMINATOR'S DEVICE HISTORY RECORDS AND STERILIZATION CERTIFICATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER RELATED INCIDENTS AGAINST THE REMAINING PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. THE INITIAL REPORTING STATED NO ADDITIONAL INVESTIGATIONAL INPUTS WERE AVAILABLE. 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

    PATIENT WAS REVISED TO ADDRESS POSSIBLE INFECTION. CUP WAS FOUND TO BE LOOSE. THERE WAS METAL DEBRIS INSIDE THAT LINER THAT APPEARED TO BE "COATING" FROM THE GRIPTION CUP. THIS CAUSED MARKS ON THE BIOLOX HEAD. POLY WEAR OF THE LINER WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125600 ALTRX +4 NEUT 36IDX52OD ACETABULAR LINER LPH 1818910 DEPUY ORTHOPAEDICS, INC. 199159

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention