BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX - FEMORAL COMPONENT PRECOAT SIZE E LEFT

    MDR report key: 6413419 · Received March 17, 2017

    Report

    Report Number
    3007963827-2017-00030
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    February 17, 2017
    Report Date
    September 12, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    NJL
    PMA / PMN Number
    PSEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): NEXGEN LPS-FLEX - FEMORAL COMPONENT PRECOAT SIZE E LEFT, CATALOG #: 00596001551, LOT #: 62856808; NEXGEN LPS-FLEX - ARTICULAR SURFACE WITH LOCKING SCREW SIZE EF 17 MM HEIGHT, CATALOG #: 00596403217, LOT #: 62187612; UNKNOWN NEXGEN TIBIAL TRAY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3007963827-2017-00030, 0001822565-2017-01774, 0001822565-2017-06403. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: NEXGEN LPS-FLEX - ARTICULAR SURFACE WITH LOCKING SCREW SIZE EF 17 MM HEIGHT, CATALOG #: 00596403217, LOT #: 62187612. (B)(4). THIS PRODUCT IS MANUFACTURED BY ZIMMER ORTHOPAEDIC MFG. LTD., (B)(4). THIS DEVICE IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P060037. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2017-01774. CUSTOMER HAS NOT YET INDICATED IF PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LESS THAN ONE YEAR FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT UNDERWENT A REVISION OF THE ARTICULAR SURFACE AND FEMORAL COMPONENT DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195565 NEXGEN LPS-FLEX - FEMORAL COMPONENT PRECOAT SIZE E LEFT PROSTHESIS, KNEE NJL ZIMMER ORTHOPAEDIC MFG. LTD. 62856808

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R