BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD CR TIB BRG 63/67X10

    MDR report key: 7802796 · Received August 21, 2018

    Report

    Report Number
    0001825034-2018-08413
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    July 18, 2018
    Report Date
    March 28, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    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

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT DETERMINED THAT IT HAS CRACKED/BROKEN IN THE POSTERIOR MEDIAL PORTION. SMALL NICKS AND GOUGES WERE ALSO FOUND ON THE BEARING. MATERIAL ANALYSIS ON THE RETURNED PRODUCT CONFIRMED THAT THE PRODUCT WAS MADE OF THE CORRECT MATERIAL PER PRINT SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES. A DEFINITIVE ROOT CAUSE CANNOT 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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG # 141222 BIOMET CC I-BEAM TRAY 67 MM LOT # J33353267, CATALOG # 184762 SERIES A PAT STD 28 3 PEG LOT # 478000, CATALOG # 185816 VANGUARD PSR INTLK FEM LT 70 LOT # 942870. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 PATIENT UNDERWENT KNEE REVISION SURGERY APPROXIMATELY 4 YEARS AFTER INITIAL SURGERY DUE TO LIGAMENT LAXITY, DURING THE PROCEDURE IT WAS NOTICED THAT THE TIBIAL BEARING HAD CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643475 E1 VNGD CR TIB BRG 63/67X10 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 706820

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R