BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRUCIATE RETAINING CR-FLEX (GSF) FEMORAL COMPONENT POROUS

    MDR report key: 14756746 · Received June 21, 2022

    Report

    Report Number
    0001822565-2022-01848
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    May 30, 2014
    Report Date
    August 19, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    K072619
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2022-01849. CONCOMITANT MEDICAL PRODUCTS: ARTICULAR SURFACE 10 MM HEIGHT, ITEM#: 00595203010, LOT#: 62390230. STEMMED TIBIAL COMPONENT PRECOAT SIZE 3, ITEM#: 00598003701, LOT#: 62491588. ALL POLY PETELLA STANDARD CEMENTED SIZE 32 MM DIAMETER 8.5 MM THICKNESS, ITEM#: 00597206532, LOT#: 62549288. REPORT SOURCE - AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: NO COMPLICATION WAS NOTED DURING THE INITIAL SURGERY. THE PATIENT WAS REVISED FOR PAIN. DURING THE SURGERY MCL WAS RUPTURED AND IT WAS REPAIRED. BOTH FEMUR AND ARTICULAR SURFACE WERE REVISED, AND NO COMPLICATION WAS NOTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO RELATED DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER PACKAGE INSERT 87-6203-762-22: PAIN IS KNOWN ADVERSE EFFECT OF THE SYSTEM. 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. H6: COMPONENT CODE: PROPOSED COMPONENT (ANNEX G) CODE IS MECHANICAL G4-FEMUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO LIGAMENT FAILURE. DURING THE REVISION THE MEDIAL COLLATERAL LIGAMENT RUPTURE WAS REPAIRED, AND NEW FEMORAL AND ARTICULAR SURFACE COMPONENTS WERE PLACED WITHOUT COMPLICATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    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
    595840 CRUCIATE RETAINING CR-FLEX (GSF) FEMORAL COMPONENT POROUS PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 62426476

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10.