BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGC V2 POROUS TIB 83 X 10MM

    MDR report key: 11955819 · Received June 8, 2021

    Report

    Report Number
    3002806535-2021-00243
    Event Type
    Injury
    Date Received
    June 8, 2021
    Date of Event
    May 10, 2021
    Report Date
    July 9, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    MBH
    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. 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. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. 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 : DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE 16 YEARS AGO. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO TIBIAL LOOSENING WAS PERFORMED ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT: REPORT SOURCE, FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT HAS BEEN DISCARDED. (ASSOCIATED PRODUCT): MEDICAL PRODUCT: AGC V2 UNIV POR/HA COAT FEM 70, CATALOG #:150524, LOT #: 1193482. 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 AN UNKNOWN DATE 16 YEARS AGO. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO TIBIAL LOOSENING WAS PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850884 AGC V2 POROUS TIB 83 X 10MM KNEE ARTHROPLASTY MBH BIOMET UK LTD. N/A S927793

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10