BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F RIGHT

    MDR report key: 10178323 · Received June 22, 2020

    Report

    Report Number
    3007963827-2020-00157
    Event Type
    Injury
    Date Received
    June 22, 2020
    Date of Event
    November 19, 2019
    Report Date
    September 16, 2020
    Manufacturer
    ZIMMER ORTHOPAEDIC MFG. LTD.
    Product Code
    JWH
    PMA / PMN Number
    K060370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED NO CEMENT ADHERES TO THE IMPLANT AND SOME SCRATCHES WERE SEEN IN THE FEMORAL CONDYLE. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT 87-6203-762-22, NEXGEN CR-FLEX AND LPS-FLEX, GSF KNEE FEMORAL COMPONENTS: LOOSENING IS A KNOWN ADVERSE EFFECT OF THESE SYSTEMS. 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 · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: MEDICAL PRODUCT. STEMMED TIBIAL COMPONENT PRECOAT SIZE 5, ITEM#: 00598004701, LOT#: 62703212. ARTICULAR SURFACE SIZE EF 10 MM HEIGHT, ITEM#: 00596204010, LOT#: 62502525. ALL POLY PATELLA STANDARD SIZE, ITEM#: 00597206532, LOT#: 62710284. PALACOS R + G (1X40), ITEM#: 66022663, LOT#: 78834388.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: UNKNOWN NEXGEN ARTICULAR SURFACE. REPORT SOURCE - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 A PATIENT WAS REVISED DUE TO ASEPTIC FEMORAL LOOSENING. THERE WAS NO CEMENT ADHESION TO THE BACK OF THE NEXGEN LPS FEMORAL COMPONENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642238 FEMORAL COMPONENT OPTION FOR CEMENTED USE ONLY SIZE F RIGHT PROSTHESIS, KNEE JWH ZIMMER ORTHOPAEDIC MFG. LTD. N/A 62244836

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R