BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD XP INLK PRI TIB TRAY 73MM

    MDR report key: 7262766 · Received February 12, 2018

    Report

    Report Number
    0001825034-2018-00825
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    October 16, 2014
    Report Date
    February 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK122160
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS OF ALL THE PRODUCT FOUND NO DEVIATION AND ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. COMPATIBILITY CHECK FOR THE PARTS: 195406, 195335, 195250 AND 195203 WAS CARRIED OUT AND WAS FOUND TO BE COMPATIBLE. A COMPLAINT HISTORY REVIEW DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. RELATED MFR REPORTS: 0001825034-2018-00824, 0001825034-2018-00826, 0001825034-2018-00827. CONCOMITANT PRODUCTS: ITEM 195203 ¿ LOT 747020 - VGXP INTLK FMRL RT 60; ITEM 195335 ¿ LOT 515150 - VGXP XP E1 TIB BRG RL 12X71; ITEM 195406 ¿ LOT 883780 - VGXP XP E1 TIB BRG RM 13X71.

    Description of Event or Problem · 1

    CLINICAL STUDY 504 - IT WAS REPORTED THAT 6 MONTHS POST A TOTAL KNEE ARTHROPLASTY PROCEDURE THAT WAS CARRIED OUT ON THE RIGHT KNEE ON (B)(6) 2014, THE PATIENT REPORTED MODERATE PAIN AND DISCOMFORT ALONG WITH PROBLEMS IN WALKING ABOUT. IT WAS ALSO REPORTED THAT THE PATIENT FOUND IT IMPOSSIBLE TO KNEEL. IT WAS REPORTED THAT THE PATIENT FOUND IT DIFFICULT TO WALK DOWN STAIRS AND EXPERIENCED SEVERE ANTERIOR KNEE PAIN. SATISFACTION RATING AT 6 MONTHS WAS "VERY HAPPY," ALTHOUGH THE PATIENT REPORTED USE OF A CANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107366 VNGD XP INLK PRI TIB TRAY 73MM PROSTHESIS - KNEE MBH ZIMMER BIOMET, INC. N/A 936210

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other