BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RGX 3 PEG SER A PATELLA 34MM

    MDR report key: 6681721 · Received June 30, 2017

    Report

    Report Number
    0001825034-2017-04506
    Event Type
    Injury
    Date Received
    June 30, 2017
    Date of Event
    November 18, 2015
    Report Date
    October 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK083782
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCT: VNGD PS+ TIB BRG 24X71/75MM. CAT#: 183754 LOT#: 486500. BIOMET TIBIAL LOCKING BAR, CAT#: 141205 LOT#: 984380. TI PPS VG PS CLSD BOX 62.5 RT, CAT#: CP115732 LOT#: 837170. BIOMET FINNED PRI STEM 80X15MM, CAT#: 141320 LOT#: 884540. BMET REGENX PRI TIB TRAY 71MM, CAT#: 141273 LOT#: 770260. PRODUCT IS CURRENTLY NOT EXPECTED TO RETURN TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH 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: 0001825034-2017-04501, 0001825034-2017-04502, 0001825034-2017-04503, 0001825034-2017-04504, 0001825034-2017-04505, 0001825034-2017-04506. REMAINS IMPLANTED.

    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. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. IN ASSOCIATED PACKAGE INSERT, ITS STATES THAT THE PATIENT IS TO BE MADE AWARE AND WARNED OF GENERAL SURGICAL RISKS, POSSIBLE ADVERSE EFFECTS IN ADVANCE AS LISTED, AND TO FOLLOW THE INSTRUCTIONS OF THE TREATING PHYSICIAN INCLUDING FOLLOW-UP VISITS. PER THE PROVIDED MEDICAL RECORDS THE LONGLASTING HISTORY OF PATIENTS LOWER EXTREMITY VARICOSE VEINS AND PATIENT REMAINING SYMPTOMATIC DESPITE CONSERVATIVE MANAGEMENT LED TO PERFORMING AMBULATORY PHLEBECTOMY. HOWEVER, A ROOT CAUSE FOR INFLAMMATION WAS UNABLE TO BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER THE INVESTIGATION OF THIS EVENT. 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 HAD AN AMBULATORY STAB PHLEBECTOMY FOR VARICOSE VEINS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463452 RGX 3 PEG SER A PATELLA 34MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 983930

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention