BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX PATELLA 3 PEG POROUS TITANIUM 37MM

    MDR report key: 6746609 · Received July 27, 2017

    Report

    Report Number
    0001825034-2017-05074
    Event Type
    Injury
    Date Received
    July 27, 2017
    Report Date
    September 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK083782
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCT: CATALOG #: 141358, REGENEREX PATELLA 3 PEG POROUS TITANIUM 37MM, LOT # 838450; CATALOG #: 183052, VANGUARD FEMORAL POROUS COATED 70MM RIGHT, LOT # 496490; CATALOG #: 141275, REGENEREX PRIMARY TIBIAL TRAY WITH LOCKING BAR 7MM, LOT # 519610; CATALOG #: 141314, MAXIM BIOMET KNEE SYSTEM MODULAR FINNED STEM 40MM, LOT # 299790; CATALOG #: EP-183560, VANGUARD TIBIAL BEARING 10MM X 79/83MM, LOT # 050730. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO DEVICE BEING STILL IMPLANTED IN THE PATIENT. 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: 0001825034-2017-05078, 05079, 05080, AND 05082. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 BILATERAL KNEE ARTHROPLASTY AND IS NOW REPORTING OCCASIONAL PAIN IN HIS KNEES, CRAMPS IN HIS SHINS, AND BEHIND HIS KNEES. HIS DOCTOR TOLD HIM THAT HIS PATELLA BUTTONS WERE RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527194 REGENEREX PATELLA 3 PEG POROUS TITANIUM 37MM PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS 838450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention