BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY

    MDR report key: 7220926 · Received January 25, 2018

    Report

    Report Number
    0001825034-2018-00311
    Event Type
    Injury
    Date Received
    January 25, 2018
    Date of Event
    December 27, 2017
    Report Date
    December 3, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK833921
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. X-RAYS WERE PROVIDED AND REVIEWED BY A HCP. REVIEW OF THE RADIOGRAPHS IDENTIFIED LOOSENING AND SUBSIDENCE OF FEMORAL AND TIBIAL COMPONENTS ON THE LATER X-RAYS ACQUIRED BEFORE REVISION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED.DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES 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.

    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: VANGUARD PS OPEN FEMORAL CAT#: 183130, LOT#: 850270, BIOMET CC CRUCIATE TRAY CAT#: 141234, LOT#: J2662790 , VANGUARD PS TIBIAL BEARING AT#: 183642, LOT#: 428420 . FOREIGN: (B)(6). 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 - 2018 - 00310, 0001825034 - 2018 - 00311. PRODUCT LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: VANGUARD FEM PEGS SET 2 CATALOG # 183099 LOT # 080590; SERIES A PAT STD 34 3 PEG CATALOG # 184766 LOT # 067830. REPORTER HAD INDICATED THAT PRODUCT WILL BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FIVE YEARS AFTER TOTAL KNEE ARTHROPLASTY DUE TO TIBIAL AND FEMORAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62018 BIOMET CC CRUCIATE TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J2662790

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R