BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN LPS FEMORAL COMPONENT

    MDR report key: 5681331 · Received May 26, 2016

    Report

    Report Number
    3007963827-2016-00038
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    October 22, 2015
    Report Date
    May 5, 2017
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    NJL
    PMA / PMN Number
    PP060037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATIONTION PROVIDED ON THIS REPORT WAS PREVIOUSLY SUBMITTED ON MANUFACTURING REPORT NUMBER 0001822565-2016-01299. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION, WHICH WAS INCORRECT OR WAS NOT AVAILABLE AT THE TIME OF INITIAL FOLLOW UP. THIS REPORT IS BEING AMENDED TO REFLECT CHANGES IN SECTIONS. CORRECTION MADE TO: PATIENT INITIALS ARE (B)(6). DEVICE PRODUCT CODE- NJL. (B)(4). MEDICAL PRODUCT ¿ ZIMMER NEXGEN OPTION LPS FEMORAL COMPONENT, SIZE F, LEFT CATALOG# 00-5996-016-51, (B)(4), ZIMMER NEXGEN LPS-FLEX ARTICULAR SURFACE EF 5-6, 12MM CATALOG# 00-5964-040-12, (B)(4), ZIMMER NEXGEN PRECOAT STEMMED TIBIAL PLATE, YELLOW STRIPED, SIZE 4 CATALOG# 00-5980-047-02, (B)(4), ZIMMER NEXGEN ALL-POLY PATELLA, 35MM X 9.0MM CATALOG# 00-5972-065-35, (B)(4), PALACOS N-ANTIBIOTIC BONE CEMENT CATALOG# 00-1112-140-01, 76654363 AND (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE COMPATIBILITY MATRIX IDENTIFIED THAT ALL THE COMPONENTS ARE COMPATIBLE (FEMORAL WITH ARTICULAR SURFACE AND PATELLA; TIBIA WITH ARTICULAR SURFACE). SURGICAL NOTES WERE PROVIDED; IT IDENTIFIED THAT THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. MOREOVER, SURGEON FOUND FEMORAL COMPONENT WAS GROSSLY LOOSE BUT TIBIAL COMPONENT WAS STABLE. DEVICE HISTORY RECORD REVIEW FOUND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO NEW TRENDS WERE IDENTIFIED. NEXGEN KNEE SYSTEM PACKAGING INSERT STATES, "LOOSENING OR FRACTURE/DAMAGE OF THE PROSTHETIC KNEE COMPONENTS OR SURROUNDING TISSUES" AND "WEAR DEBRIS CAN INITIATE OSTEOLYSIS WHICH MAY RESULT IN LOOSENING OF THE IMPLANT" AS KNOWN RISKS OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED WITH THE INFORMATION 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2016-01768-2, 0001822565-2016-01770-2.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING LOOSENING OF THE FEMORAL COMPONENT. IT WAS FOUND FEMORAL COMPONENT WAS GROOSLY LOOSE BUT TIBIAL COMPONENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337975 NEXGEN LPS FEMORAL COMPONENT JWH NJL ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62286161

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O