BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING ARCOM RIGHT MEDIAL

    MDR report key: 6663959 · Received June 23, 2017

    Report

    Report Number
    3002806535-2017-00534
    Event Type
    Injury
    Date Received
    June 23, 2017
    Date of Event
    May 24, 2017
    Report Date
    December 14, 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER - (B)(4). UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS - OXFORD PARTIAL KNEE SYSTEM TWIN PEG FEMORAL, CATALOG # 161469 LOT, # 261680 AND OXFORD PARTIAL KNEE SYSTEM RIGHT MEDIAL TIBIAL TRAY, CATALOG# 154727, LOT # 031250. 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. PRODUCT EXPECTED, NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 THE PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FIVE MONTHS POST-IMPLANTATION DUE TO UNKNOWN REASONS. THE POLYETHYLENE BEARING WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY FIVE MONTHS POST-IMPLANTATION DUE POLY BEARING MIGRATION. THE POLYETHYLENE BEARING WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443342 OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING ARCOM RIGHT MEDIAL PROSTHESIS, KNEE NRA BIOMET UK LTD. 760490

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R