BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD PS+ TIB BRG 71/75X10

    MDR report key: 10970258 · Received December 8, 2020

    Report

    Report Number
    0001825034-2020-04294
    Event Type
    Injury
    Date Received
    December 8, 2020
    Date of Event
    June 29, 2020
    Report Date
    April 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OIY
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: CATALOG # 141356, REGENEREX 3 PEG SERIES A PATELLA DCM ARCOM POROUS TITANIUM LOT # 561780. CATALOG #: 184512, VNGD PS OPEN POR FMRL RT 70, LOT # 421160. CATALOG #: 141316, BIOMET FINNED PRI STEM 80X10MM, LOT # 980570. CATALOG #: 141274, BMET REGENX PRI TIB TRAY 75MM, LOT # 504580. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2019-01920.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE APPROXIMATELY TWO YEARS AGO. SUBSEQUENTLY, THE PATIENT SUFFERED PAIN IN THE KNEE JOINTS AND HAS A FRACTURED PATELLA. FURTHER IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE PAIN, IMPLANT FRACTURE, METALLOSIS, NECROTIC TISSUE AND BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429502 E1 VNGD PS+ TIB BRG 71/75X10 PROSTHESIS, KNEE OIY ZIMMER BIOMET, INC. N/A 403580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R