BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD CR TIB BRG 79/83X10

    MDR report key: 7832132 · Received August 30, 2018

    Report

    Report Number
    0001825034-2018-08594
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    July 3, 2018
    Report Date
    April 3, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI : (B)(4). THE REPORTED EVENT WAS CONFIRMED AS PRODUCT WAS RETURNED AND VISUAL EXAMINATION OF THE RETURNED TIBIAL TRAY CONFIRMED THAT THE PRODUCT FRACTURED. ANALYSIS OF THE TIBIAL TRAY FRACTURE SURFACE DETERMINED THAT THE PRODUCT EXPERIENCED A FATIGUE FRACTURE BEGINNING POSTERIORLY AND MOVING ANTERIORLY AT AN ANGLE. REVIEW OF THE PROVIDED RADIOGRAPHS BY A HEALTH CARE PROFESSIONAL SHOWS A FRACTURED MEDIAL TIBIAL PLATE WITH UNDERLYING OSTEOPENIA AND LUCENCY SUGGESTING OSTEOLYSIS. REVIEW OF THE PROVIDED OP-NOTES BY A HEALTH CARE PROFESSIONAL IDENTIFIED SIGNIFICANT FIBROTIC TISSUE AND METALLOSIS AS WELL AS BONE CYSTS ON THE MEDIAL TIBIAL PLATEAU WERE NOTED DURING THE REVISION. THERE WAS NO SIGN OF INFLAMMATION OR INFECTION FOUND DURING THE REVISION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. AT THIS TIME A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AS IT IS UNKNOWN WHAT CAUSED THE NOTED OSTEOLYSIS. 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

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2018-04876. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: BMET REGENX PRI TIB TRAY 79MM; ITEM# 141275 LOT# 811240. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE AND SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE. AFTER REGULAR FOLLOW UP X-RAYS WERE TAKEN AT THE SURGEONS' OFFICE, THE SURGEON NOTED THAT THE REGENEREX TIBIAL IMPLANT APPEARED TO BE BENT OR FRACTURED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674746 E1 VNGD CR TIB BRG 79/83X10 PROSTHESIS- KNEE JWH ZIMMER BIOMET, INC. N/A 214680

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R