BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX TIBIAL TRAY

    MDR report key: 6901888 · Received September 28, 2017

    Report

    Report Number
    0001825034-2017-07573
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    May 24, 2017
    Report Date
    November 3, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK080361
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: REGENEREX 3 PEG PATELLA, CAT#: 141357 LOT#: 684980, REGENEREX TIBIAL TRAY, CAT#: 141273 LOT#: 875660, REGENEREX TIBIAL TRAY, CAT#: 141273 LOT#: 875660, BIOMET FINNED STEM, CAT#: 141314 LOT#: 063000. 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: 0001825034-2017-06535, 0001825034-2017-07571.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 0001825034-2017-07105.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY ONE YEAR POST-IMPLANTATION DUE TO PAIN, DIFFICULTY BEARING WEIGHT, SLIGHT EFFUSION, LIMP, AND SWELLING. SURGEON TOLD PATIENT THAT THE IMPLANT WAS NOT SEATED PROPERLY AND THE DISK PART WAS LOOSE. ALL COMPONENTS WERE REMOVED AND REPLACED. OPERATIVE REPORTS INDICATE THAT THERE WAS LACK OF BONY INGROWTH ON THE FEMORAL COMPONENT, BUT IT WAS NOT OBVIOUSLY LOOSE. THE PATELLA COMPONENT ALSO SHOWED NO EVIDENCE OF BONY INGROWTH AND WAS LOOSE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681908 REGENEREX TIBIAL TRAY PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 875660

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R