BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNGD XP INLK PRI TIB TRAY 69MM

    MDR report key: 7279532 · Received February 18, 2018

    Report

    Report Number
    0001825034-2018-01045
    Event Type
    Injury
    Date Received
    February 18, 2018
    Date of Event
    June 26, 2014
    Report Date
    February 20, 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

    THIS COMPLAINT REMAINS CLOSED, AS THE CORRECTED INFORMATION DOES NOT AFFECT THE OUTCOME OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01044, 0001825034-2018-01046, 0001825034-2018-01047. MEDICAL DEVICES: CAT 195203 ¿ LOT 568760 - VGXP INTLK FMRL RT 60, CAT 195332 ¿ LOT 946010 - VGXP XP E1 TIB BRG RL 9X71, CAT 195402 ¿ LOT 970040 - VGXP XP E1 TIB BRG RM 9X71. PRODUCT WAS NOT RETURNED AND NO PHOTOS OF THE DEVICE WERE PROVIDED; THEREFORE, NO EVALUATIONS COULD BE CONDUCTED. THE REPORTED DEVICES ARE USED FOR TREATMENT. THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED: PN 195203 LN 568760; PN 195248 LN 752060; PN 195332 LN 946010; PN 195402 LN 970040. REVIEW OF THE OPERATIVE RECORD INDICATES THAT THE SURGEON NOTED NO COMPLICATIONS. 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.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6)- THE PATIENT UNDERWENT SURGERY FOR RIGHT KNEE ON (B)(6) 2014 AND DURING THE FOLLOW UPS IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES, MODERATE PAIN IN RIGHT KNEE DURING HER 3 MONTH AND 6 MONTH FOLLOW UP VISITS. MODERATE PAIN, MODERATELY PAINFUL TO STAND UP, OFTEN LIMPING, IMPOSSIBLE TO KNEEL, PAIN IN BED MOST NIGHTS, PAIN HAS MODERATELY INTERFERED WITH USUAL WORK, MODERATELY DIFFICULT TO WALK DOWN STAIRS, MODERATE CONTINUAL PAIN IN RIGHT KNEE DURING ONE YEAR FOLLOW UP VISIT. PATIENT REPORTED USE OF A CANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122782 VNGD XP INLK PRI TIB TRAY 69MM PROSTHESIS - KNEE MBH ZIMMER BIOMET, INC. N/A 752060

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention