BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX KNEE

    MDR report key: 16681880 · Received April 5, 2023

    Report

    Report Number
    1226188-2023-00099
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    April 4, 2023
    Report Date
    October 12, 2023
    Manufacturer
    OMNILIFE SCIENCE INC.
    Product Code
    JWH
    UDI-DI
    00841690101970
    PMA / PMN Number
    K060192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL REPORT: THE DEVICE MANUFACTURING RECORDS WILL BE LOCATED AND REVIEWED. CONCLUSIONS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. ADDITIONAL INFORMATION, SUCH AS OPERATIVE NOTES, PATIENT ACTIVITY LEVEL, MEDICAL HISTORY AND WEIGHT, IF PATIENT EXPERIENCED ANY TRAUNMA AND AN UPDATE ON THE PATIENT WAS REQUESTED IN ORDER TO PERFORM THE INVESTIGATION. IF PROVIDED THEY WILL BE SUMMARIZED IN A SUPPLEMENTAL REPORT. 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.

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY DATE IS ON (B)(6) 2016. THE REASON FOR REVISION IS REPORTED INSTABILITY/PATELLA DISLOCATION. DURING THE REVISION, INSERT, PATELLA AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. THE COMPLAINANT MADE NO INDICATION OF ANY OMNILIFE SCIENCE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCE CONTRIBUTING TO THE ADVERSE EVENT. ACCORDING TO THE INTAKE FORM, THE PRODUCTS ARE NOT AVAILABLE FOR RETURN AND EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION AND STERILIZATION DOCUMENTATION FOR THE DEVICES IN QUESTION REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. BELOW IS A SUMMARY OF THE DOCUMENTATION INVESTIGATION: REF: KC-40358 PATELLA LOT NUMBER: 23811, DATE OF MANUFACTURE: 06/30/2016, DATE OF EXPIRATION: 06/30/2021, STERILE BATCH: OLS164047, REF: KC-20410 TIBIAL INSERT SIZE 4 ,10MM LOT NUMBER: 20617, DATE OF MANUFACTURE: 06/30/2015, DATE OF EXPIRATION: 06/30/2020, STERILE BATCH: OLS154044, REF: KP-20010 RETAINING BOLT LOT NUMBER: 21967, DATE OF MANUFACTURE: 10/31/2015, DATE OF EXPIRATION: 10/31/2020, STERILE BATCH: OLS154088 CAUSE CANNOT BE DETERMINED. REVISION SURGERIES HAVE MANY VARIABLES INCLUDING NUMEROUS PATIENT CONDITIONS THAT CONTRIBUTE TO THE EVENT TAKING PLACE. NO ACTION WAS TAKEN AS A RESULT OF THIS COMPLAINT. 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 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.

    Description of Event or Problem · 0

    APEX REVISION AFTER APPROXIMATIVELY 7 YEARS DUE TO INSTABILITY (PATIENT DISLOCATED GOING UPSTAIRS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2257468 APEX KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH OMNILIFE SCIENCE INC. KC-40358 23811 00841690101970

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H APEX BOLT - MODEL 20010 LOT 21967.| APEX PS INSERT SIZE 4 - MODEL KP-20410 LOT 20617.