BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N-K FLEX ALL-POLY PATELLA

    MDR report key: 5717061 · Received June 10, 2016

    Report

    Report Number
    0001822565-2016-01976
    Event Type
    Injury
    Date Received
    June 10, 2016
    Report Date
    March 9, 2018
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK070214
    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

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN THE ASSOCIATED RISK DOCUMENTATION. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: ZIMMER NEXGEN A/P WEDGED TIBIAL COMPONENT CATALOG #: 00-5988-007-00 LOT #: 62026669, ZIMMER NEXGEN LCCK FEMORAL COMPONENT CATALOG #: 00-5994-017-91 LOT #: 62255092, ZIMMER NEXGEN LCCK ARTICULAR SURFACE CATALOG #: 00-5994-050-23 LOT #: 62285794, ZIMMER NEXGEN FULL BLOCK TIBIAL AUGMENT CATALOG #: 00-5988-007-10 LOT #: 62047932, ZIMMER NEXGEN STRAIGHT STEM EXTENSION CATALOG #: 00-5988-010-15 LOT #: 62488076, ZIMMER NEXGEN STRAIGHT STEM EXTENSION CATALOG #: 00-5988-011-17 LOT #: 62406084. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-01974, 0001822565-2016-01975, 0001822565-2016-01973, 0001822565-2017-02256, 0002648920-2017-00237, 0002648920-2017-00238.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE ROOT CAUSE ASSOCIATED WITH THE SWELLING IS BELIEVED TO BE THE NON-INDICATED USE OF THE DEVICES. A SUMMARY OF THE INVESTIGATION WILL BE SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS TREATED WITH IRRIGATION AND DEBRIDEMENT AFTER BEING REVISED, BUT STILL CONTINUES TO EXPERIENCE SWELLING AND TAKES A DAILY ANTIBIOTIC FOR INFECTION PREVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371486 N-K FLEX ALL-POLY PATELLA KNEE PROSTHESIS JWH ZIMMER, INC. 62435201

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R