BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN STRAIGHT STEM EXTENSION

    MDR report key: 6491620 · Received April 13, 2017

    Report

    Report Number
    0002648920-2017-00237
    Event Type
    Injury
    Date Received
    April 13, 2017
    Report Date
    March 9, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    NJL
    PMA / PMN Number
    PK872379
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT 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 N-K FLEX ALL-POLY PATELLA CATALOG #: 00-5420-008-02 LOT #: 62435201, ZIMMER NEXGEN FULL BLOCK TIBIAL AUGMENT CATALOG #: 00-5988-007-10 LOT #: 62047932, 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, 0001822565-2016-01976, 0001822565-2017-02256, 0002648920-2017-00238.

    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
    274138 NEXGEN STRAIGHT STEM EXTENSION KNEE PROSTHESIS NJL ZIMMER MANUFACTURING B.V. 62488076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R