BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ILOK PRI TIB TRAY 75MM

    MDR report key: 9197595 · Received October 16, 2019

    Report

    Report Number
    0001825034-2019-04661
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    K915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. UPDATED: A5, B4, B5, G4, G7. ADDITIONAL: H1, H2, H3, H6, H10. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. TIBIA WAS FOUND TO BE GROSSLY LOOSE MEDIALLY AND TILTING IN THE VARUS. A LARGE CYST WAS FOUND UNDER THE TIBIA. SURGERY TOOK AN EXTENDED AMOUNT OF TIME DUE TO PATIENT¿S HIGH BMI. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). UDI: (B)(4). MEDICAL PRODUCTS: VNGD CR TIB BRG 10X71/75 MM; P/N: 183440, L/N: 023500, VANGUARD CR ILOK FEM-RT 70; P/N: 183012, L/N: J3811641, BIOMET ILOK PRI TIB TRAY 75MM; P/N: 141214, L/N: 675450, BIOMET FINNED PRI STEM 40MM; P/N: 141314, L/N: 746780, BMET ARCOM AP PAT W/WIRE 34MM IRE 34MM; P/N: 11-150828, L/N: 238830, COMPETITOR BONE CEMENT; P/N: UNK, L/N: UNK. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04662. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A RIGHT KNEE REVISION PROCEDURE THREE (3) YEARS POST-IMPLANTATION DUE TO TIBIAL LOOSENING AND CYST FORMATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991139 BIOMET ILOK PRI TIB TRAY 75MM PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 675450

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R SEE H10 NARRATIVE.