BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI CMNTLS TIB SZ D RM

    MDR report key: 12390606 · Received August 31, 2021

    Report

    Report Number
    3002806535-2021-00360
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 22, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: 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. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 2 COMPLAINTS REPORTED WITH THE ITEMS 159578 AND 154926 AND 1 COMPLAINT REPORTED WITH THE ITEM 166577. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00361-2; 3002806535-2021-00362-2. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. H3 OTHER TEXT: PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ADDITIONAL INFORMATION RECEIVED: UPDATE TO HEALTH EFFECT - CLINICAL CODE: PAIN COMPLAINT DESCRIPTION UPDATED. PATIENT'S NAME: (B)(6). PATIENT'S AGE: 64. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00361-1. 3002806535-2021-00362-1. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL BI-LATERAL KNEE ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, A REVISION PROCEDURE ON THE RIGHT KNEE DUE TO PAIN AND WEAR WAS PERFORMED ON (B)(6) 2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL BI-LATERAL KNEE ARTHROPLASTY ON (B)(6)2018. SUBSEQUENTLY, A REVISION PROCEDURE ON THE RIGHT KNEE DUE TO PAIN AND WEAR WAS PERFORMED ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00361, 3002806535-2021-00362. 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 BI-LATERAL KNEE ARTHROPLASTY ON (B)(6) 2018. SUBSEQUENTLY, A REVISION PROCEDURE ON THE RIGHT KNEE DUE TO UNKNOWN REASON WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300746 OXF UNI CMNTLS TIB SZ D RM OXFORD CEMENTLESS TIBIAL TRAYS NRA BIOMET UK LTD. N/A 6246244

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R