BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENEREX 3-PEG PATELLA

    MDR report key: 6809940 · Received August 22, 2017

    Report

    Report Number
    0001825034-2017-06535
    Event Type
    Injury
    Date Received
    August 22, 2017
    Date of Event
    May 24, 2017
    Report Date
    November 3, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBH
    PMA / PMN Number
    PK083782
    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

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCT: VANGUARD CRUCIATE RETAINING FEMORAL, CAT#: 183048 LOT#: 579970. REGENEREX TIBIAL TRAY, CAT#: 141273 LOT#: 875660. VANGUARD TIBIAL BEARING, CAT#: EP-183540 LOT#: 586670. REGENEREX TIBIAL TRAY, CAT#: 141273 LOT#: 875660. BIOMET FINNED STEM, CAT#: 141314 LOT#: 063000. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06535, 0001825034-2017-07571, 0001825034-2017-07573.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: E1 VNGD CRL TIB BRG 71/75X10, CAT#: EP-183540, LOT#: 586670. BMET REGENX PRI TIB TRAY 71MM, CAT#: 141273, LOT#: 875660. BIOMET FINNED PRI STEM 40MM, CAT#: 141314, LOT#: 063000. VANGUARD CR POR FEM-RT 65, CAT#: 183048, LOT#: 579970. 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 SUBMITTED TO RELAY ADDITIONAL INFORMATION. THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 0001825034-2017-04863.

    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. 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. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY WAS REVISED DUE TO PAIN AND SWELLING. SURGEON TOLD PATIENT THAT THE IMPLANT WAS NOT SEATED PROPERLY AND THE DISK PART WAS LOOSE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590422 REGENEREX 3-PEG PATELLA PROSTHESIS, KNEE MBH BIOMET ORTHOPEDICS N/A 684980

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R