BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR +4 10D 36IDX52OD

    MDR report key: 3082969 · Received April 29, 2013

    Report

    Report Number
    1818910-2013-16209
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    December 4, 2008
    Report Date
    April 10, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK033273
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES B59BC1000 AND CN9CD1000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 2551349 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) WPC (B)(4). REASON FOR ORIGINAL COMPLAINT: THE PATIENT WAS REVISED BECAUSE OF LEG LENGTH DISCREPANCY. DOI: (B)(6) 2008, DOR: (B)(6) 2008 (LEFT SIDE). **UPDATE: 4/10/2013 - LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN. THE MDR DECISION FOR THE STEM AND HEAD HAVE BEEN REVERSED AND BOTH PRODUCTS REPORTED. THE LINER IS NOW BEING REPORTED ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184100 PINN MAR +4 10D 36IDX52OD METAL LINER LPH DEPUY ORTHOPAEDICS INC US CN9CD1000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention