MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 70MM

Model Number	25001070E
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the patient's stiffness of the knee was unable to be definitively determined.The patient's medical history is unknown.The surgeon believed that the patient was noncompliant with her rehabilitation regiment and that this may have caused the issue.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
Event or Problem Description
A (b)(6)-year-old female patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to joint stiffness of the knee which led to decreased range of motion.The sales representative stated that the surgeon believed that the patient was noncompliant with her rehabilitation.A 70mm male-female midsection that was placed during the primary surgery, which took place on (b)(6) 2020, was explanted, and replaced with a 60mm male-female midsection.This was done to increase the range of motion of the knee.An 8mm poly spacer was explanted during the revision which was placed during the primary surgery.This was replaced with a 12mm poly spacer.During the revision, the distal femur component, tibial hinge component, and distal femur axial pin.

• Brand Name: ELEOS
• Common Device Name: MALE-FEMALE MIDSECTION, 70MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11603551
• Report Number: 3013450937-2021-00029
• Device Sequence Number: 3668010
• Product Code: KRO
• UDI-Device Identifier: B27825001070E0
• UDI-Public: B27825001070E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 25001070E
• Device Catalogue Number: 25001070E
• Device Lot Number: 1785075
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR