BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS 3PEG MOD ROT PAT CEM SM+

    MDR report key: 2162233 · Received July 7, 2011

    Report

    Report Number
    1818910-2011-11268
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 9, 2011
    Report Date
    January 3, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MBH
    PMA / PMN Number
    MM 33-41
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES AND PROVIDED PATIENT X-RAYS BY DEPUY MATERIALS SCIENCE FINDS THE UNUSUAL GREY STAINING OF TISSUES AND WEAR OF THE POLYETHYLENE PATELLAR COMPONENT OBSERVED AT REVISION APPEAR TO HAVE RESULTED FROM MALPOSITION OF THE PATELLAR IMPLANTS ON THE PATIENT'S PATELLA. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. A REVIEW OF DEVICE HISTORY RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE EVENT. BASED ON THE PERFORMED INVESTIGATION, THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR. THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE DATABASES DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. THE AS400 LOT TRACEABILITY BY PRODUCT LOT SHOWS OTHER UNITS OF THE REPORTED PRODUCT / LOT COMBINATION HAVE BEEN DELIVERED / BILLED TO END CUSTOMERS AND ASSUMED IMPLANTED. REVIEW OF THE X-RAYS CONFIRMED THE GAP BALANCE OF THE PATELLA BUTTON APPEARS TO BE LESS MEDIAL IN COMPARISON TO THE LATERAL SIDE. NO OTHER OBSERVATIONS COULD BE MADE. 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. REPEATED ATTEMPTS TO OBTAIN THE COMPLAINT SAMPLES PROVED UNSUCCESSFUL. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / 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 HAS RECENTLY PRESENTED WITH PAIN ON THE MEDICAL SIDE OF THE LEFT KNEE. ON OPENING THE JOINT, EXTENSIVE WEAR WAS NOTED ON THE PATELLA POLYETHYLENE BEARING. SOME GREY STAINING WAS ALSO NOTED IN THE SOFT TISSUE SURROUNDING THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS 3PEG MOD ROT PAT CEM SM+ 87 MBH MBH DEPUY ORTHOPAEDICS, INC. NA X5ELC1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention