BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET REGENERX PRI TIBIAL TRAY

    MDR report key: 9316180 · Received November 13, 2019

    Report

    Report Number
    0001825034-2019-05117
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    March 25, 2019
    Report Date
    February 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. PATIENT WAS EXPERIENCING INSTABILITY AND SUSTAINED AND IATROGENIC INJURY TO THE MCL. ALL COMPONENTS WERE REPLACED WITH NO COMPLICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT IS EXAMINATION/TREATMENT RELATED, AND NOT DEVICE RELATED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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: E1 VNGD AS TIB BRG; P/N: EP-189044, L/N: 697660, BMET REGENX PRI TIB TRAY; P/N: 141272, L/N: 982200, BIOMET FINNED PRI STEM; P/N: 141314, L/N: 623440, VANGUARD CR POR FMRL; P/N: 183066, L/N: 190740, SERIES A PAT STD; P/N: 184762, L/N: 508380, PALACOS RG 1X40 SINGLE; P/N: 00111314001, L/N: 84344539. 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 - 05116, 0001825034 - 2019 - 05118, 0001825034 - 2019 - 05119, 0001825034 - 2019 - 05120. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION PROCEDURE 2 APPROXIMATELY YEARS POST-IMPLANTATION DUE TO TISSUE DAMAGE, LIMITED MOBILITY, INSTABILITY, KNEE IN VALGUS, INSUFFICIENT MEDICAL COLLATERAL LIGAMENT (MCL), AND PAIN. SUBSEQUENTLY, ALL COMPONENTS WERE REVISED. DURING THE PROCEDURE, THE SURGEON ATTEMPTED TO RECONSTRUCT THE MCL WITH AN ALLOGRAFT; HOWEVER, THE NEW ALLOGRAFT RESTRAINED FLEXION AND STABILITY. THEREFORE, THE PATIENT'S HAMSTRING TENDON WAS HARVESTED AND ANCHORED FOR RECONSTRUCTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108542 BIOMET REGENERX PRI TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 982200

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R