BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PH3 CEMENTLESS FEM SZ M

    MDR report key: 9896866 · Received March 30, 2020

    Report

    Report Number
    3002806535-2020-00187
    Event Type
    Injury
    Date Received
    March 30, 2020
    Date of Event
    March 3, 2020
    Report Date
    July 23, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: B4, B5, G4, G7, H1, H2, H3, H6, H10. G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN UNITED KINGDOM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00186-1, 3002806535-2020-00188-1. A: PATIENT INFORMATION IS NOT ALLOWED BY COUNTRY REGULATIONS. D10: PRODUCT HAS NOT BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, BECAUSE IT IS UNAVAILABLE BY HOSPITAL POLICY. 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 ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THESE ITEMS 159576 AND 166577 , 1 SIMILAR COMPLAINT FOR 154926. NO TREND IDENTIFIED. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: REGULATORY ASSESSMENT DETERMINES THAT THE RISK ASSESSMENT REMAINS WITHIN THE ACCEPTABLE LIMITS IDENTIFIED IN THE RISK MANAGEMENT REPORT. OCCURRENCE: SINCE NO ROOT CAUSE CAN BE DETERMINED FROM THE INFORMATION PROVIDED, OCCURRENCE HAS NOT BEEN CALCULATED. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, DUE TO A SUSPECTED INFECTION THE PATIENT WAS REVISED TO PERSONA IMPLANTS AS TEMPORARY SPACER.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF ANAT BRG RT MD SIZE 4 PMA, CATALOG #: 159576, LOT #: 6461002. MEDICAL PRODUCT: OXF UNI CMNTLS TIB SZ D RM, CATALOG #: 166577, LOT #: 6456382. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00186, 3002806535-2020-00188. POSTAL CODE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, DUE TO A SUSPECTED INFECTION THE PATIENT WAS REVISED TO PERSONA IMPLANTS AS TEMPORARY SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360229 OXFORD PH3 CEMENTLESS FEM SZ M UNICONDYLAR KNEE PROSTHESIS HRY BIOMET UK LTD. N/A 6472762

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R