BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG LM 9X71

    MDR report key: 7287751 · Received February 21, 2018

    Report

    Report Number
    0001825034-2018-01244
    Event Type
    Injury
    Date Received
    February 21, 2018
    Date of Event
    February 17, 2015
    Report Date
    February 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK132873
    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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: A 0001825034-2018-01242, 0001825034-2018-01241, 0001825034-2018-01243. CONCOMITANT PRODUCTS: CAT 192214 ¿ LOT 277260 - VNGD XP INTLK FMRL LT; CAT 195756 ¿ LOT 468170 ¿ VGXP XP INLK PRI TIB TRAY; CAT 195814 ¿ LOT 538140 ¿ VGXP XP E1 TIB BRG LL. REVIEW OF DEVICE HISTORY RECORDS FOUND NO DEVIATIONS OR ANOMALIES. PRODUCTS WERE NOT RETURNED AND NO PHOTOS OF THE DEVICES WERE PROVIDED; THEREFORE, NO EVALUATIONS COULD BE CONDUCTED. THE REPORTED DEVICES ARE USED FOR TREATMENT. THE REPORTED COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. A COMPLAINT HISTORY REVIEW FOR ITEM 195884 IDENTIFIED 25 ADDITIONAL COMPLAINTS FOR PAIN THAT WERE INVESTIGATED. THREE ADDITIONAL COMPLAINTS FOR PAIN WERE FOUND FOR ITEM 195884 LOT 074760 COMBINATION. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCTS, 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 504 REPORTED THAT, FOLLOWING A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED ON (B)(6) 2014, THE PATIENT REPORTED EXPERIENCING PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES, MODERATE PAIN, MODERATELY PAINFUL TO STAND UP, LIMPING OFTEN EXTREMELY DIFFICULT TO KNEEL, PAIN HAS MODERATELY INTERFERED WITH WORK, FELT KNEE WOULD GIVE WAY OFTEN AND HOUSEBOUND. THIS WAS REPORTED DURING A 6 MONTH FOLLOW UP APPOINTMENT. DURING A 1 YEAR FOLLOW UP APPOINTMENT, THE PATIENT REPORTED EXPERIENCING - PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES, MODERATE PAIN, LIMPING OFTEN, EXTREMELY DIFFICULT TO KNEEL, PAIN HAS MODERATELY INTERFERED WITH WORK, MODERATELY DIFFICULT TO SHOP. THE PROCEDURE WAS PERFORMED ON THE LEFT KNEE. THE OPERATIVE TIME WAS REPORTED AS 97 MINUTES, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. UPDATED JANUARY 30, 2018: PATIENT SATISFACTION SCORES ARE BEING ADDED. AT 3 AND 6 MONTHS FOLLOW-UP VISITS PATIENT WAS VERY SATISFIED; AT ONE YEAR FOLLOW-UP PATIENT WAS SATISFIED. UPDATED 08 FEB 2018; NURSE'S ASSESSMENT: PT HAD VERY MILD TO NO PAIN AT 3MO AND A VERY SATISFIED/VERY HAPPY RATING , BY 6MO AND ONE YEAR POST OP , PT SATISFACTION AND ADLS DECREASED- WALKING <5 BLOCKS, CAN ONLY WALK 5-15 MIN, MODERATE DIFFICULTY WITH HOUSEHOLD SHOPPING, AND PAIN INCREASES TO MODERATE CONTINUAL WITH WALKING AND STAIRS. THESE ARE NOT NORMAL OR EXPECTED FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130161 VGXP XP E1 TIB BRG LM 9X71 PROSTHESIS - KNEE MBH ZIMMER BIOMET, INC. N/A 074760

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other