BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    MDR report key: 6132180 · Received November 29, 2016

    Report

    Report Number
    3007963827-2016-00077
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 23, 2015
    Report Date
    January 18, 2018
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    PK060370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. CONCOMITANT PRODUCTS: NEXGEN COMPLETE KNEE ALL POLY PATELLA, CATALOGUE # 00597206529, LOT # 62460884; NEXGEN STEMMED TIBIAL COMPONENT, CATALOGUE # 00598003701 LOT# 62510191; NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE, CATALOGUE # 00596203210 LOT # 62436930.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: NEXGEN COMPLETE KNEE ALL POLY PATELLA, CATALOGUE # 00597206529, LOT # 62460884. NEXGEN STEMMED TIBIAL COMPONENT, CATALOGUE # 00598003701 LOT# 62510191. NEXGEN LPS-FLEX PROLONG ARTICULAR SURFACE, CATALOGUE # 00596203210 LOT # 62436930. PALACOS BONE CEMENT CATALOG# 00111214001 LOT# 77114365.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA REVISION OPERATIVE NOTES. OPERATIVE NOTES STATE, THE PROCEDURE WAS INDICATED FOR ASEPTIC LOOSENING OF THE LEFT KNEE PROSTHESIS. THE INITIAL SOFT TISSUE INCISIONS WERE MADE AND IT WAS NOTED THAT THE PATELLA WAS NOTED TO BE STABLE AND THE BUTTON WELL FIXED AND WAS THUS NOT REMOVED. THE FEMORAL COMPONENT WAS REMOVED WITH MINIMAL BONE LOSS. ATTENTION WAS TURNED TO THE TIBIAL COMPONENT AND IT WAS REMOVED WITH NO BONE LOSS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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 UNDERWENT REVISION OF THE LEFT KNEE DUE TO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN AND LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782569 NEXGEN LPS-FLEX GSF FEMORAL COMPONENT KNEE PROSTHESIS JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62503718

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R