BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX TIBIAL COMPONENTS - TIBIAL TRAY 71MM

    MDR report key: 6395832 · Received March 10, 2017

    Report

    Report Number
    0001825034-2017-01492
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 9, 2017
    Report Date
    October 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: E1 VANGUARD TIBIAL BEARING: CATALOG EP-189066, LOT 663750. BIOMET FINNED STEM 40MM: CATALOG 141314, LOT 465480. VANGUARD RIGHT FEMUR 70MM: CATALOG 167032, LOT 3850747. SERIES A PATELLA: CATALOG 184700, LOT 279760. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01493 AND 0001825034-2017-01494.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. LOOSENING OF THE TIBIAL COMPONENT WITH APPARENT SUBSIDENCE OF THE LATERAL TIBIAL TRAY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO THE PATIENT'S CONDITION AS THE MCL DAMAGED CAUSED THE IMPLANTS TO LOOSEN, HOWEVER, IT IS UNKNOWN WHAT CAUSED THE MCL DAMAGE. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE MONTHS POST IMPLANTATION DUE TO LOOSENING CAUSED BY MEDIAL COLLATERAL LIGAMENT DAMAGE. THE TIBIAL TRAY, STEM, AND BEARING WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179285 REGENEREX TIBIAL COMPONENTS - TIBIAL TRAY 71MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 091570

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R