BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ALL POLY PATELLA

    MDR report key: 5786512 · Received July 12, 2016

    Report

    Report Number
    0002648920-2016-00931
    Event Type
    Injury
    Date Received
    July 12, 2016
    Report Date
    August 9, 2017
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZIMMER NEXGEN ARTICULAR SURFACE CATALOG #: 00-5964-040-10 LOT #: 61789652. ZIMMER NEXGEN FEMORAL COMPONENT CATALOG #: 00-5996-016-52 LOT #: 61788569. ZIMMER NEXGEN TIBIAL COMPONENT CATALOG #: 00-5980-047-01 LOT #: 61787685. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THIS IS REPORT 4 OF 4 FOR THIS PATIENT. SEE ALSO 0001822565-2016-02325-1, 3007963827-2016-00051-1, AND 0002648920-2016-00929-1. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE TIBIAL AND PATELLAR COMPONENTS IDENTIFIED NO DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE ARTICULAR SURFACE IDENTIFIED ONE ANOMALY DURING OPERATION 9000 (SEAL AND PACK). ONE UNIT WAS IDENTIFIED TO NOT HAVE BEEN ENGRAVED AND WAS SCRAPPED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE FEMORAL COMPONENT IDENTIFIED ONE ANOMALY DURING OPERATION 1200 (SONIC CLEAN AND PENETRANT INSPECT). ONE UNIT WAS FOUND TO HAVE AN INCLUSION AND WAS SCRAPPED. THE ANOMALIES WOULD NOT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT AS THE AFFECTED UNITS WERE SCRAPPED. THIS DEVICE IS USED FOR TREATMENT. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER COMPLAINTS FOR L/N 61789652, 61788569, 61787685, OR 61781507. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REVIEW OF THE IMPLANTED COMPONENTS IDENTIFIED NO COMPATIBILITY ISSUES. PER THE NEXGEN CR-FLEX AND LPS-FLEX PACKAGE INSERT, SWELLING AND POOR RANGE OF MOTION ARE KNOWN RISKS OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. DATE OF EVENT - 2017. .DATE OF EXPLANT - 2017.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING KNEE SWELLING, REDNESS, AND DIFFICULTY BENDING HER KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION DUE TO UNKNOWN REASONS APPROXIMATELY 6 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439089 NEXGEN ALL POLY PATELLA KNEE PROSTHESIS JWH ZIMMER MANUFACTURING B.V. N/A 61781507

    Patients

    Seq Age Sex Outcome Treatment
    1 Other