BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX PRECOAT FEMORAL COMPONENT LEFT SIZE G

    MDR report key: 6631886 · Received June 9, 2017

    Report

    Report Number
    0001822565-2017-03975
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    May 10, 2017
    Report Date
    October 25, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    NJL
    PMA / PMN Number
    PP060037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICE(S):- NEXGEN STEMMED LCCK PRECOAT TIBIAL COMPONENT, ITEM # 00598005702, LOT # 61731003. NEXGEN ALL STANDARD POLY PATELLA SIZE 35MM, ITEM # 00597206535, LOT # 61852895. NEXGEN HEADED SCREW 48MM, ITEM # 00579104100, LOT # 61792614. NEXGEN ARTICULAR SURFACE SIZE GH 12MM, ITEM # 00596405012, LOT 61406114. NEXGEN LPS-FLEX PATIENT SPECIFIC PIN GUIDE, ITEM # 00597000002, LOT # UNKNOWN. THE LOT NUMBER REPORTED 11.043234 IS NOT VALID FOR THE NEXGEN LPS-FLEX PATIENT SPECIFIC PIN GUIDE . FOREIGN SOURCE- (B)(6. PMA 510(K): THIS DEVICE IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER P060037. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO THE DEVICE BEING DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULITIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0002648920-2017-00386.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCT WAS RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD  (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE REPORTED COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 WAS REPORTED FOLLOWING A KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF THE TIBIA AND FEMORAL COMPONENTS. SURGEON NOTED CEMENT FAILURE AS POOR CEMENT INTERDIGITATION INTO THE BONE AND NO CEMENT LEFT ON THE FEMORAL COMPONENT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412906 NEXGEN LPS-FLEX PRECOAT FEMORAL COMPONENT LEFT SIZE G PROSTHESIS, KNEE NJL ZIMMER, INC. 61328496

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R