BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX TIBIAL COMPONENTS

    MDR report key: 6709945 · Received July 13, 2017

    Report

    Report Number
    0001825034-2017-04903
    Event Type
    Injury
    Date Received
    July 13, 2017
    Date of Event
    June 12, 2017
    Report Date
    October 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER: - (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCT: VANGUARD COMPLETE KNEE SYSTEM, CAT#: 183074, LOT#: 676570. REGENEREX TIBIAL COMPONENTS, CAT# 141276, LOT#: 600840. REGENEREX PATELLA COMPONENTS, CAT#: 141358, LOT#: 044820. MICROPLASTY TIBIAL TRAYS, CAT#: 141205, LOT#: 432770. VANGUARD COMPLETE KNEE SYSTEM, CAT#: 189120, LOT#: 507120. VANGUARD COMPLETE KNEE SYSTEM, CAT#: 189100, LOT#: 392140. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [PRODUCT LOCATION UNKNOWN AT THIS TIME]. 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: 0001825034-2017-04901, 0001825034-2017-04902, 0001825034-2017-04903, 0001825034-2017-04904, 0001825034-2017-04905, 0001825034-2017-04906, 0001825034-2017-04907. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AND SHOULD NOT HAVE BEEN REPORTED. THE INITIAL REPORT SHOULD BE VOIDED AS IT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED, ELEVEN MONTHS AFTER INITIAL IMPLANTATION, DUE TO AN INFECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492888 REGENEREX TIBIAL COMPONENTS PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 588030

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R