BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET REGENEREX 3 PEG SERIES A PATELLA

    MDR report key: 6595507 · Received May 26, 2017

    Report

    Report Number
    0001825034-2017-03457
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    July 12, 2017
    Report Date
    February 9, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK083782
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD TITANIUM PPS CLOSED BOX FEMORAL - RIGHT 62.5 MM, ITEM #: CP115732, LOT #: 837170. BIOMET FINNED PRIMARY STEM 80X15 MM, ITEM #: 141320, LOT #: 884540. BIOMET REGENEREX PRIMARY TIBIAL TRAY 71 MM, ITEM #: 141273, LOT #: 770260. VANGUARD PS+ TIBIAL BEARING 24X71/75 MM, ITEM #: 183754, LOT #: 486500. BIOMET TIBIAL LOCKING BAR, ITEM #: 141205, LOT #: 984380. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT IS STILL IMPLANTED. 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: 0001825034-2017-03453, 0001825034-2017-03454, 0001825034-2017-03455, 0001825034-2017-03452 AND 0001825034-2017-03458.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION WAS PERFORMED. THE TIBIAL TRAY WAS ASSEMBLED WITH THE STEM. THE BEARING EXHIBITS HEAVY GOUGES AND DENTS ON MULTIPLE SURFACES. THE BEARING'S ARTICULATING SURFACE HAS SCRATCHES IN THE DIRECTION OF ARTICULATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ALL THE METAL COMPONENTS THAT WERE IMPLANTED INTO THE PATIENT ARE MADE OF TI-6AL-4V ALLOY WHICH DOESN'T CONTAIN THE ABOVE-MENTIONED COMPONENTS WHICH THE PATIENT WAS ALLERGIC TO. THE COMPONENTS ARE PRESS-FIT AND NO BONE CEMENT WAS USED TO IMPLANT THE PRODUCT. THE ROOT CAUSE FOR THE RECURRING EFFUSIONS AND PAIN CANNOT BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 HAS BEEN REPORTED THAT FOLLOWING A REVISION OF THE TIBIAL BEARING, THE PATIENT CONTINUES TO EXPERIENCE EXTREME SWELLING IN HER KNEE. SHE BELIEVES SHE IS HAVING AN ALLERGIC REACTION TO THE DEVICES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT IS FURTHER REPORTED THAT THE PATIENT WAS REVISED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT FOLLOWING A REVISION OF THE TIBIAL BEARING, THE PATIENT CONTINUES TO EXPERIENCE EXTREME SWELLING IN HER KNEE. SHE BELIEVES SHE IS HAVING AN ALLERGIC REACTION TO THE DEVICES. ADDITIONAL INFORMATION RECEIVED INDICATED PATIENT IS SCHEDULED FOR A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375108 BIOMET REGENEREX 3 PEG SERIES A PATELLA PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 983930

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention