BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 32IDX48OD

    MDR report key: 2111381 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-07450
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K033273
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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

    VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE TO SUPPORT DISASSOCIATION OF THE LINER AND CUP WHILE IMPLANTED. AS REPORTED THESE DEVICES REMAINED IMPLANTED FOR AN EXTENDED TIME AFTER THE DISASSOCIATION EVENT. THE EXTENSIVE DAMAGE PRESENT MAKES ANY DETERMINATIONS AS TO ROOT CAUSE DIFFICULT. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE THEIR RELEASE FOR DISTRIBUTION. PATIENT X-RAYS WERE REQUESTED TO ASSESS CUP POSITION AND AID IN THIS INVESTIGATION BUT NONE WERE PROVIDED. THROUGH PRODUCT TRENDING, THE OCCURRENCE RATE FOR THIS TYPE OF FAILURE IS KNOWN TO BE VERY SMALL. BASED ON THE PERFORMED INVESTIGATION, PRODUCT ERROR WAS NOT IDENTIFIED AND A NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE OF THE LINER DISASSOCIATED FROM THE CUP. IT WAS NOTED THE PT JUMPED OUT OF A TRUCK AND FELT A POP IN HER HIP, SHE HAD CLICKING AND PAIN IN THE MONTHS FOLLOWING. POLY WEAR WAS ALSO NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR +4 10D 32IDX48OD 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA DK6E51

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention