BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE SYSTEM

    MDR report key: 17728011 · Received September 12, 2023

    Report

    Report Number
    1226188-2023-00134
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    August 28, 2023
    Report Date
    November 23, 2023
    Manufacturer
    OMNILIFE SCIENCE INC.
    Product Code
    JWH
    PMA / PMN Number
    K102578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FINAL REPORT: ADDITIONAL INFORMATION INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES (PRIMARY AND REVISION), PATIENT ACTIVITY LEVEL AND MEDICAL HISTORY AND AN UPDATE ON THE PATIENT POST REVISION HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION OF THIS EVENT. HOWEVER NO FURTHER INFORMATION WAS PROVIDED AND THEREFORE THE SCOPE OF THE EVENT WAS LIMITED. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING AND STERILIZATION RECORDS WERE IDENTIFIED AND REVIEWED. REVIEW OF THESE RECORDS REVEALED NO DEVIATION FROM PROCESS OR PRODUCT NON-CONFORMITY THAT WOULD HAVE CAUSED THE REPORTED EVENT. INFECTION IS A KNOWN COMPLICATION WITH ANY INVASIVE SURGERY. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE INFECTION IS UNKNOWN AND THUS THIS CASE IS NOW CONSIDERED CLOSED. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT. THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. THE APEX LOCKING BOLT KP-20010, LOT: 30663 WAS NOT REVISED: IT WAS LEFT IN SITU.

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT: THE APPROPRIATE DEVICE DETAILS WERE PROVIDED. THE MANUFACTURING RECORDS WILL BE IDENTIFIED AND WILL BE REVIEWED. ADDITIONAL INFORMATION WAS REQUESTED, SUCH AS XRAYS, OPERATIVE NOTES, PATIENT ACTIVITY LEVEL AND MEDICAL HISTORY AND AN UPDATE ON THE PATIENT POST REVISION. CONCLUSIONS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT. THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 0

    APEX TIBIAL INSERT REVISION FOR INFECTION AFTER 4 YEARS AND 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642806 APEX KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH OMNILIFE SCIENCE INC. KP-20210 29912

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H APEX FEMUR KP-0025L LOT 30267| APEX LOCKING BOLT KP-20010 LOT 30663| APEX PATELLA KC-40328 LOT 29627| APEX TIBIAL BASEPLATE KC-2202L LOT 30368