BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT LG SIZE 4 PMA

    MDR report key: 11862149 · Received May 21, 2021

    Report

    Report Number
    3002806535-2021-00212
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 11, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P01004
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A4, B7, D4, D6, G3, H1, H2, H4, H6, H10. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00213-1, 3002806535-2021- 00214-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED, 2 SCARP PIECES FOUND FOR ITEM 159583. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 COMPLAINT REPORTED WITH THE ITEM 159583, 7 COMPLAINTS REPORTED WITH THE ITEM 161470 AND 1 COMPLAINT REPORTED WITH THE ITEM 154776 (INCLUDING INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH CEMENTED OXFORD PARTIAL KNEE SYSTEM. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. THE SEVERITY OF THE REPORTED EVENT IS IN LINE WITH THE RISK FILE, AND NO ISSUE WITH THE OCCURRENCE RATE HAS BEEN IDENTIFIED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON (B)(6) 2020. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO SWELLING WAS PERFORMED ON (B)(6), 2021.

    Additional Manufacturer Narrative · 1

    (B)(6). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT HAS BEEN DISCARDED/LOCATION UNKNOWN. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM LG PMA, CATALOG #: 161470, LOT #: 497040. MEDICAL PRODUCT: OXF UNI TIB TRAY SZ F RM PMA, CATALOG #: 154776, LOT #: 672950. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00213, 3002806535-2021- 00214 THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ITEMS THROWN AWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO SWELLING WAS PERFORMED ON (B)(6) 2021. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758824 OXF ANAT BRG RT LG SIZE 4 PMA KNEE ARTHROPLASTY NRA BIOMET UK LTD. N/A 236380

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R (B)(4).