BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP E1 TIB BRG RM 9X71

    MDR report key: 7262763 · Received February 12, 2018

    Report

    Report Number
    0001825034-2018-00815
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    October 7, 2014
    Report Date
    February 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK122160
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT PRODUCTS: ITEM 195203 ¿ LOT 088070 - VGXP INTLK FMRL RT 60. ITEM 195248 ¿ LOT 919220 - VNGD XP INLK PRI TIB TRAY 69MM. ITEM 195332 ¿ LOT 792780 - VGXP XP E1 TIB BRG RL 9X71. 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 195402 LN 946150 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 088070. PN 195248 LN 919220. PN 195332 LN 792780. PN 195402 LN 946150. 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. RELATED REPORTS: MFR RPT 0001825034-2018-00812, MFR RPT 0001825034-2018-00813, MFR RPT 0001825034-2018-00814.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6) - IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT KNEE SURGERY ON (B)(6) 2014. SUBSEQUENTLY, POST-OPERATIVE PAIN AND OTHER EXPERIENCES WERE REPORTED AT THE FOLLOW UP VISITS: THREE MONTH EQ5D MODERATE PAIN AND PROBLEMS PERFORMING USUAL ACTIVITIES; 6 MONTH: EQ5D - PROBLEMS PERFORMING USUAL ACTIVITIES, MODERATE PAIN, OXFORD - EXTREMELY DIFFICULT TO KNEEL, PAIN HAS MODERATELY INTERFERED WITH USUAL WORK, MODERATELY DIFFICULT TO WALK DOWN STAIRS AND MKSS - MODERATE PAIN; 1 YEAR: EQ5D - PROBLEMS WALKING, PROBLEMS PERFORMING USUAL ACTIVITIES, MODERATE PAIN, OXFORD -MODERATE PAIN, ONLY 5-15 MINUTES BEFORE SEVERE PAIN ON WALKING, LIMPING MOST OF THE TIME, MODERATELY DIFFICULT TO KNEEL, PAIN IN BED MOST NIGHTS, MODERATELY INTERFERED WITH USUAL WORK, MODERATELY DIFFICULT TO WALK DOWN STAIRS AND MKSS - MODERATE PAIN; AND 2 YEAR: MKSS MODERATE PAIN. AT THIS TIME THERE IS NO INDICATION OF SURGICAL DELAYS OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107218 VGXP XP E1 TIB BRG RM 9X71 PROSTHESIS - KNEE JWH ZIMMER BIOMET, INC. N/A 946150

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other