BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP INTLK FMRL RT 60

    MDR report key: 7279533 · Received February 18, 2018

    Report

    Report Number
    0001825034-2017-10878
    Event Type
    Injury
    Date Received
    February 18, 2018
    Date of Event
    January 16, 2015
    Report Date
    December 5, 2017
    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). CONCOMITANT PRODUCTS: CAT#195248; LOT#984380 - VNGD XP INLK PRI TIB TRAY 69MM, CAT#195402; LOT#986570 - VGXP XP E1 TIB BRG RM 9X71, CAT#195332; LOT#986490 - VGXP XP E1 TIB BRG RL 9X71. RELATED MFR REPORTS: 0001825034-2017-10886, 0001825034-2017-10889, 0001825034-2017-10890. PRODUCT WAS NOT RETURNED AND NO PHOTOS OF THE DEVICE WERE PROVIDED; THEREFORE, NO EVALUATIONS COULD BE CONDUCTED. REVIEW OF DEVICE HISTORY RECORDS FOR PN 195203 LN 088070 FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. THE REPORTED DEVICES ARE USED FOR TREATMENT. THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED: PN 195203 LN 088070; PN 195248 LN 984380; PN 195332 LN 986490; PN 195402 LN 986570. A COMPLAINT HISTORY REVIEW FOR ITEM 195203 IDENTIFIED 24 OTHER COMPLAINTS FOR EVENT "PAIN", THAT WERE INVESTIGATED AND IT WAS DETERMIND THAT NO FURTHER ACTION IS REQUIRED DUE TO THE EVENT BEING ADDRESSED IN THE MONTHLY TRENDING MEETING. 6 ADDTIONAL COMPLAINTS WERE FOUND ITEM 195203 LOT 088070 COMBINATION. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6)- THE PATIENT UNDERWENT RIGHT KNEE SURGERY ON (B)(6) 2014. IT WAS REPORTED THAT THE PATIENT WAS USING CRUTCHES OR A WALKER AT 7 WEEKS POST-OP. DURING THE 3 MONTH FOLLOW UP VISIT THAT THE PATIENT REPORTED PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES, EXTREME PAIN, IMPOSSIBLE TO WALK DOWN STAIRS. SATISFACTION RATING WAS "VERY UNSATISFIED/I HAVE NEVER BEEN HAPPY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122787 VGXP INTLK FMRL RT 60 PROSTHESIS - KNEE MBH ZIMMER BIOMET, INC. N/A 088070

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other