BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING LEFT MEDIAL 4MM THICK

    MDR report key: 6393605 · Received March 9, 2017

    Report

    Report Number
    3002806535-2017-00114
    Event Type
    Injury
    Date Received
    March 9, 2017
    Date of Event
    February 10, 2017
    Report Date
    December 22, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: OXFORD TWIN PEG CEMENTED FEMUR: CATALOG 161467, LOT 483410. OXFORD TIBIAL TRAY: CATALOG 154722, LOT 219560. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO SHOW NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS DUE THE PATIENT NOT FOLLOWING THE SURGEON¿S POST-OPERATIVE ADVICE. 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 WAS REVISED APPROXIMATELY THREE MONTHS POST IMPLANTATION DUE TO DISLOCATION CAUSED BY THE PATIENT SQUATTING IN DEEP FLEXION; FURTHER THAN RECOMMENDED BY THE SURGEON. THE TIBIAL BEARING WAS REPLACED WITH A THICKER SIZE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175282 OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING LEFT MEDIAL 4MM THICK PROSTHESIS, KNEE NRA BIOMET UK LTD. 918370

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R