BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM LEFT SIZE 3

    MDR report key: 14730861 · Received June 17, 2022

    Report

    Report Number
    3002806535-2022-00280
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    May 10, 2022
    Report Date
    July 1, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279785933
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF TWIN PEG CMNTLS FMRL MD ITEM# 161474 ,LOT# 3050585, OXFORD CEMENTLESS TIBIA D LM ITEM# US166576, LOT# 3050478. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2022 - 00279, 3002806535 - 2022 - 00281.

    Additional Manufacturer Narrative · 0

    (B)(4). THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, G3, G6, H1, H2, H3,H6, H10. THE DEVICE HISTORY RECORDS FOR ITEM # 159547 LOT # 825760 WERE REVIEWED FOR DEVIATIONS AND / OR ANOMALIES WITH NO ANOMALIES / DEVIATIONS IDENTIFIED. ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A CLINICAL STUDY THAT THE PATIENT DEVELOPED PAINFUL PES ANSERINUS BURSA ON THE LEFT KNEE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION. PATIENT IS BEING TREATED WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS. NO REVISION OR FURTHER OUTCOME REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261839 OXFORD PKS ANATOMIC ARCOM MENISCAL BRG - MEDIUM LEFT SIZE 3 KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A 825760 05019279785933

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention