BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG RL 9X71

    MDR report key: 7279548 · Received February 18, 2018

    Report

    Report Number
    0001825034-2018-01065
    Event Type
    Injury
    Date Received
    February 18, 2018
    Date of Event
    February 6, 2014
    Report Date
    February 16, 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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01063; 0001825034-2018-01064; 0001825034-2018-01073; CONCOMITANT PRODUCTS: CAT 195203 ¿ LOT 990310 - VGXP INTLK FMRL RT; CAT 195249 ¿ LOT 752080 ¿ VGXP XP INLK PRI TIB TRAY; CAT 195402 ¿ LOT 820130 - VGXP XP E1 TIB BRG RM. PRODUCT WAS NOT RETURNED AND NO PHOTOS OF THE DEVICE WERE PROVIDED; THEREFORE, NO EVALUATIONS COULD BE CONDUCTED. REVIEW OF THE DEVICE HISTORY RECORDS FOR PN 195332 LN (B)(4) IDENTIFIED 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 (B)(4); PN 195249 LN (B)(4); PN 195332 LN (B)(4); PN 195402 LN (B)(4). THE COMPLAINT HISTORY FOR ITEM WAS REVIEWED AND IT WAS DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 504 -IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT KNEE SURGERY ON 06 FEB 2014. SUBSEQUENTLY, POST-OPERATIVE PAIN AND OTHER EXPERIENCES WERE REPORTED AT THE FOLLOW UP VISITS: 3 MONTH EQ5D - PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES AND MODERATE PAIN; MKSS - MODERATE PAIN; 6 MONTH EQ5D - PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES, MODERATE PAIN; OXFORD - MODERATE PAIN, MODERATE TROUBLE GETTING IN OR OUT OF CAR, VERY PAINFUL TO STAND UP, LIMPING ALL OF THE TIME, IMPOSSIBLE TO KNEEL, PAIN HAS MODERATELY INTERFERED WITH USUAL WORK, MODERATELY DIFFICULT TO SHOP ON OWN AND MODERATELY DIFFICULT TO WALK DOWN STAIRS; MKSS - MODERATE PAIN; 1 YEAR - EQ5D - PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES, MODERATE PAIN; OXFORD - SEVERE PAIN, MODERATE TROUBLE GETTING IN OR OUT OF CAR, SEVERE PAIN ON WALKING, VERY PAINFUL TO STAND UP, LIMPING MOST OF THE TIME, EXTREMELY DIFFICULT TO KNEEL, PAIN HAS GREATLY INTERFERED WITH USUAL WORK, MODERATELY DIFFICULT TO WALK DOWN STAIRS; MKSS - MODERATE PAIN; 2 YEAR - EQ5D - PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES, MODERATE PAIN; OXFORD - MODERATE PAIN, MODERATE TROUBLE GETTING IN OR OUT OF CAR, 5-15 MINUTES BEFORE SEVERE PAIN ON WALKING, VERY PAINFUL TO STAND UP, LIMPING MOST OF THE TIME, IMPOSSIBLE TO KNEEL, PAIN HAS GREATLY INTERFERED WITH USUAL WORK, OFTEN FELT KNEE WOULD GIVE WAY, MODERATELY DIFFICULT TO WALK DOWN STAIRS. AT THIS TIME THERE IS NO INDICATION OF SURGICAL DELAYS OR MEDICAL INTERVENTION. SATISFACTION RATINGS WERE: 6-MONTH - NONE RECORDED; 1-YEAR - "NOT SATISFIED/I HAVE NEVER BEEN HAPPY;" 2-YEAR - "NOT SATISFIED/I HAVE NEVER BEEN HAPPY." AT THE 6-MONTH VISIT, THE PATIENT REPORTED USING A CANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122814 VGXP XP E1 TIB BRG RL 9X71 PROSTHESIS - KNEE MBH ZIMMER BIOMET, INC. N/A 702760

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention