BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS PFJ TROCHLEAR COMP SM+ RT

    MDR report key: 1833234 · Received September 9, 2010

    Report

    Report Number
    1818910-2010-06516
    Event Type
    Injury
    Date Received
    September 9, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    NJL
    PMA / PMN Number
    P830055/S085
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCT TO EXAMINE. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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. THE INITIAL OPERATIVE REPORT AND IMPLANT SUMMARY RECORD WERE SUPPLIED FOR REVIEW. THE OPERATIVE REPORT IS BRIEF AND THE PREOPERATIVE DIAGNOSIS WAS DEGENERATIVE ARTHRITIS, RIGHT KNEE/CHRONIC PATELLOFEMORAL PAIN. THE OPERATIVE REPORT IS BRIEF AND DOES NOT SUGGEST ANY COMPLICATIONS OR DEVIATIONS FROM THE RECOMMENDED SURGICAL TECHNIQUE. THERE ARE NO PATIENT PAST MEDICAL HISTORY REPORTS OR COMORBIDITIES AVAILABLE. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED EVENT OR DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. 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

    PT REVISED FOR PAIN AND POLYETHYLENE WEAR OF PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS PFJ TROCHLEAR COMP SM+ RT NJL DEPUY ORTHOPAEDICS, INC. NA CY4GX1000

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention