BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY

    MDR report key: 7135617 · Received December 20, 2017

    Report

    Report Number
    0001825034-2017-11301
    Event Type
    Injury
    Date Received
    December 20, 2017
    Report Date
    April 4, 2018
    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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: VANGUARD FEM PEGS SET 2 CATALOG # 183099, LOT # 611020; VAN PS OPEN INTL FEM-RT 62.5 CATALOG # 183106, LOT # 833000; SERIES A PAT STD 31 3 PEG CATALOG # 184764, LOT # 596500; OSC FAN BLADE S2K HUB CATALOG # 506096, LOT # 952033. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN A THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: E1 VANGUARD TIBIAL BEARING CAT#: EP-183621, LOT#: 976050. FOREIGN: (B)(4) . CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034 - 2017 - 11301, 0001825034 - 2017 - 11302.: PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION AFTER TOTAL KNEE ARTHROPLASTY DUE TO TIBIAL LOOSENING. SMALL HOLES WERE SEEN ON THE EXPLANTED BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913694 BIOMET CC CRUCIATE TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3563876

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10