BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MBT POR TIBIAL TRAY SZ4

    MDR report key: 6190542 · Received December 20, 2016

    Report

    Report Number
    1818910-2016-33735
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    April 12, 2016
    Report Date
    April 12, 2017
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT DATABASE SEARCH DID NOT IDENTIFY ANY ANOMALIES. A REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. WITHOUT FURTHER INFORMATION THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. POST MARKET SURVEILLANCE IS PER (B)(4). 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.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT REMAINS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATES LIABILITY CLAIM: ORIGINAL IMPLANTATION (B)(6) 2012. PATIENT HAD TO HAVE A REVISION OF THE PROSTHESIS ON (B)(6) 2016 DUE TO AN INFLAMMATORY REACTION WHICH WAS CAUSED BY METAL PARTICLES OF WHICH IT WAS BELIEVED THAT THEY CAME LOOSE OF THE PROSTHESIS. A COMPLAINT DATABASE SEARCH DID NOT IDENTIFY ANY ANOMALIES. A REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. WITHOUT FURTHER INFORMATION THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. IF FURTHER INFORMATION IS RECEIVED THE COMPLAINT SHALL BE REOPENED AND INVESTIGATED FURTHER. POST MARKET SURVEILLANCE IS (B)(4). THE COMPLAINT WAS REOPENED AS X-RAYS WERE RECEIVED ON CD. THE X-RAYS WERE REVIEWED AS (B)(4). NO IMPLANT FRACTURE OR DISASSOCIATION WAS NOTED THE CONCLUSION REMAINS UNCHANGED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT'S TRANSLATED MEDICAL RECORDS WERE RECEIVED. MEDICAL RECORDS WERE REVIEWED FOR MDR REPORTABILITY. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD A SWOLLEN AND PAINFUL KNEE PRIOR TO REVISION. UPON ENTERING THE KNEE A CITRINE-COLORED INTRA-ARTICULAR EFFUSION WAS ENCOUNTERED WITH A SYNOVIUM THAT APPEARED LIKE GRAINS OF RICE. THE FEMORAL COMPONENT WAS REMOVED WITHOUT DIFFICULTY. TWO SIGNIFICANT CAVITIES UNDERTAKING ALL EXTERNAL AND LATERAL POSTERIOR CONDYLES AND ALL THE INTERNAL POSTERIOR CONDYLE CONTAINING GELATINOUS GREENISH AND YELLOWISH MATERIAL AND AN UNPLEASANT LIQUID EVOKING AN INFECTED APPEARANCE. THE TIBIAL PLATE WAS REMOVED WITHOUT DIFFICULTY AND ALSO CONTAINED A CAVITY WITH SMELLY GELATINOUT MATERIAL. A CEMENTED SPACER WAS PLACED. THE DIAGNOSIS WAS LOOSENING OF THE FEMORAL AND TIBIAL IMPLANTS IN THE X-RAY ASSESSMENT. THE PATIENT WAS REIMPLANTED ON (B)(6) 2016.

    Description of Event or Problem · 1

    LIABILITY CLAIM: ORIGINAL IMPLANTATION (B)(6) 2012. PATIENT HAD TO HAVE A REVISION OF THE PROSTHESIS ON (B)(6) 2016 DUE TO AN INFLAMMATORY REACTION WHICH WAS CAUSED BY METAL PARTICLES OF WHICH IT WAS BELIEVED THAT THEY CAME LOOSE OF THE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840443 MBT POR TIBIAL TRAY SZ4 KNEE TIBIAL TRAY NJL DEPUY IRELAND 9616671 3407191

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention