BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VGXP XP LAT TIB BRG LT 9X63

    MDR report key: 7148586 · Received December 27, 2017

    Report

    Report Number
    0001825034-2017-10912
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    March 18, 2016
    Report Date
    December 5, 2017
    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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT - (B)(4). CONCOMITANT PRODUCTS: CAT#195918; LOT#498450 - VGXP INTLK FEMORAL LT 55. CAT#195751; LOT#833150 - VANG XP INLK PRI TIB TRAY 63MM. CAT#195877; LOT#891500 - VGXP XP MED TIB BRG LT 9X63. RELATED MFR REPORTS: 0001825034-2017-10910, 0001825034-2017-10911, 0001825034-2017-10913. 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 195807, LN 759920 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 195918 LN 498450. PN 195751 LN 833150. PN 195807 LN 759920. PN 195877 LN 891500. A COMPLAINT HISTORY REVIEW WAS PERFORMED FOR PART 195807.THE SEARCH IDENTIFIED 2 ADDITIONAL COMPLAINTS FOR THE SAME OR SIMILAR ISSUE OF FRACTURE. THE SEARCH ALSO IDENTIFIED TWO OTHER COMPLAINTS FOR THE LOT (759920) WITH THE PAIN. REVIEW OF THE OPERATIVE RECORD INDICATES THAT THE SURGEON NOTED TIBIAL ISLAND DIDN'T STAY INTACT THROUGH FULL EXTENSION DURING TRAILING. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT KNEE SURGERY ON (B)(6) 2016. THE OPERATIVE RECORD INDICATED TIBIAL ISLAND DID NOT STAY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927972 VGXP XP LAT TIB BRG LT 9X63 PROSTHESIS - KNEE MBH ZIMMER BIOMET, INC. N/A 759920

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other