BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF TWIN PEG CMNTLS FMRL MD

    MDR report key: 14730785 · Received June 17, 2022

    Report

    Report Number
    3002806535-2022-00279
    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
    05019279442270
    PMA / PMN Number
    N/A
    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 ANAT BRG LT MD SIZE 3 PMA MED SZ 3 ITEM# 159547, LOT# 825760, OXFORD CEMENTLESS TIBIA D LM ITEM# US166576, LOT# 3050478. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2022 - 00280, 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 # 161474 LOT # 3050585 WERE REVIEWED FOR DEVIATIONS AND / OR ANOMALIES WITH NO ANOMALIES / DEVIATIONS IDENTIFIED.. ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. 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
    194850 OXF TWIN PEG CMNTLS FMRL MD KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A 3050585 05019279442270

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention SEE H10 NARRATIVE