BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIPAC 40 REFOBACIN BN CMT R

    MDR report key: 10739755 · Received October 27, 2020

    Report

    Report Number
    3002806535-2020-00464
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    June 1, 2011
    Report Date
    January 25, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LOD
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FINAL NOT-REPORTABLE REPORT IS BEING SUBMITTED TO MAKE A CORRECTION. UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MIR REPORT SHOULD NOT HAVE BEEN SUBMITTED UNDER THE CURRENT MANUFACTURER. THIS EVENT WILL BE REPORTED BY BIOMET FRANCE SARL (MFR REF: (B)(4)). THEREFORE, BIOMET UK LTD. WILL NOT BE SENDING ANY FOLLOW-UPS REGARDING THIS PRODUCT.

    Description of Event or Problem · 0

    THE PATIENT (ID 6354007) IS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, IT WAS DISCOVERED THAT FREE CEMENT FRAGMENT WAS BLOCKING THE JOINT. ON (B)(6) 2011, ARTHROSCOPIC SURGERY WAS PERFORMED TO REMOVE THE LOOSENED CEMENT FRAGMENT. INFORMATION RECEIVED REGARDING THE CLINICAL STUDY: OFFICIAL TITLE OF CLINICAL STUDY: POST-MARKET CLINICAL FOLLOW-UP STUDY TO PROVIDE SAFETY, PERFORMANCE AND CLINICAL BENEFITS DATA OF THE OXFORD TINBN AND VANGUARD CR TINBN KNEE SYSTEMS (IMPLANTS AND INSTRUMENTATION) ¿ A RETROSPECTIVE AND PROSPECTIVE CONSECUTIVE SERIES STUDY. STUDY TYPE: RETROSPECTIVE AND PROSPECTIVE CONSECUTIVE PMCF SERIES STUDY. RADIOGRAPHIC EVALUATIONS WILL OCCUR AT THE 7Y AND 10Y FOLLOW-UP VISIT, AS IS THE STANDARD OF CARE. PER PROTOCOL, 100 OXFORD TINBN PKS PATIENTS WILL BE ENROLLED, ALL AT THE SAME STUDY CENTER IN BAD RAPPENAU (MONOCENTRIC). THE STUDY STARTED IN (B)(6) 019 AND IS PLANNED TO COMPLETE IN 2024/2025.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: UNKNOWN OXFORD TIBIAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MEDICAL PRODUCT: UNKNOWN OXFORD FEMORAL COMPONENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MEDICAL PRODUCT: UNKNOWN OXFORD BEARING, CATALOG #: UNKNOWN, LOT #: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00461,3002806535-2020-00462, 3002806535-2020-00463. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT (ID (B)(6) IS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, IT WAS DISCOVERED THAT FREE CEMENT FRAGMENT WAS BLOCKING THE JOINT. ON (B)(6) 2011, ARTHROSCOPIC SURGERY WAS PERFORMED TO REMOVE THE LOOSENED CEMENT FRAGMENT. INFORMATION RECEIVED REGARDING THE CLINICAL STUDY: OFFICIAL TITLE OF CLINICAL STUDY: POST-MARKET CLINICAL FOLLOW-UP STUDY TO PROVIDE SAFETY, PERFORMANCE AND CLINICAL BENEFITS DATA OF THE OXFORD TINBN AND VANGUARD CR TINBN KNEE SYSTEMS (IMPLANTS AND INSTRUMENTATION) ¿ A RETROSPECTIVE AND PROSPECTIVE CONSECUTIVE SERIES STUDY. STUDY TYPE: RETROSPECTIVE AND PROSPECTIVE CONSECUTIVE PMCF SERIES STUDY. RADIOGRAPHIC EVALUATIONS WILL OCCUR AT THE 7Y AND 10Y FOLLOW-UP VISIT, AS IS THE STANDARD OF CARE. PER PROTOCOL, 100 OXFORD TINBN PKS PATIENTS WILL BE ENROLLED, ALL AT THE SAME STUDY CENTER IN BAD RAPPENAU (MONOCENTRIC). THE STUDY STARTED IN (B)(6) 2019 AND IS PLANNED TO COMPLETE IN 2024/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206982 OPTIPAC 40 REFOBACIN BN CMT R OPTIPAC REFOBACIN R LOD BIOMET UK LTD. N/A 001BAL1403

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other