BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TINBN COATED OXF TIB TRAY C LM

    MDR report key: 12266972 · Received August 3, 2021

    Report

    Report Number
    3002806535-2021-00338
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    September 1, 2019
    Report Date
    September 22, 2021
    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
    GM
    Reporter Occupation
    003

    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 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 COULD NOT BE PERFORMED AS LOT NUMBER IS UNKNOWN. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND 1 COMPLAINT REPORTED WITH THE ITEM 154601TNBN, 154722TNBN AND 159547 (INITIATING COMPLAINT). 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: 3002806535-2021-00337-1; 3002806535-2021-00339-1 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: DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, THE SURGEON REPORTED MINIMAL SWELLING OF THE IPSILATERAL KNEE AFTER PARTIAL KNEE ARTHROPLASTY WITH A TINBN-COATED IMPLANT WHICH ONSET ON (B)(6) 2019.SURGEON CATEGORIZED THE EVENT AS AN ADVERSE EVENT, WITH UNCERTAIN RELATION TO THE DEVICE AND PROBABLY RELATED TO THE PROCEDURE. PATIENT WAS TREATED WITH ICING THE KNEE AND CONSERVATIVE TREATMENT. SWELLING IS NOW NOT PERSISTENT ANYMORE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: OPTIPAC RBC 40, CATALOG NO.: UNKNOWN, LOT NO.: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS (ADD THIS FOR A MULTIPLE ITEM COMPLAINT): 3002806535-2021-00337, 3002806535-2021-00339. 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 KNEE ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, THE SURGEON REPORTED MINIMAL SWELLING OF THE IPSILATERAL KNEE AFTER PARTIAL KNEE ARTHROPLASTY WITH A TINBN-COATED IMPLANT WHICH ONSET ON (B)(6) 2019. SURGEON CATEGORIZED THE EVENT AS AN ADVERSE EVENT, WITH UNCERTAIN RELATION TO THE DEVICE AND PROBABLY RELATED TO THE PROCEDURE. PATIENT WAS TREATED WITH ICING THE KNEE AND CONSERVATIVE TREATMENT. SWELLING IS NOW NOT PERSISTENT ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166258 TINBN COATED OXF TIB TRAY C LM TINBN OXF TIB TRAYS HRY BIOMET UK LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other