BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN ARTICULAR SURFACE

    MDR report key: 13584272 · Received February 23, 2022

    Report

    Report Number
    0001822565-2022-00569
    Event Type
    Malfunction
    Date Received
    February 23, 2022
    Date of Event
    January 5, 2022
    Report Date
    September 27, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024211711
    PMA / PMN Number
    K173057
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL PRODUCT: KNE-UNKNOWN--TIBIAL TRAY, CATALOG # UNKNOWN, LOT # UNKNOWN, LPS-FLEX FXD MLD CD/1-2 14MM, CATALOG # 00-5964-022-14, LOT # 64500611, NG PS MIC PRE ST TIB PLT SZ1 CATALOG # 00-5980-027-01, LOT # 65120836, LPS OPTION FEMORAL D-R, CATALOG # 00-5996-014-52, LOT # 64791997, PALACOS R X 40GMS, CATALOG # 66057851, LOT # 60331061. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G4, G7, H1, H2, H3, H6, H10. H6: HEALTH IMPACT - TYPE OF INVESTIGATION - DEVICE NOT RETURNED IS N/A WHICH WAS REPORTED ON INITIAL REPORT. COMPLAINT SAMPLE WAS EVALUATED. VISUAL EVALUATION OF THE RETURNED DEVICE SHOWS SIGNS OF REPEATED USE AND THE DOVETAIL FEATURE IS FLARED AND COMPRESSED. THE ROOT CAUSE IS ATTRIBUTED TO USE ERROR. THE CONTACT WAS SENT THE INVESTIGATION RESULTS. 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 · 0

    IT WAS REPORTED THAT THE ARTICULAR SURFACE PROSTHESIS WOULD NOT SEAT WITH MATING DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005166 NEXGEN ARTICULAR SURFACE PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 64377309 00889024211711

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female SEE H10 NARRATIVE