MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE COMPONENT, W/ ROTATIONAL STOP

Model Number 25002100E

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Loss of Range of Motion (2032)

Event Date 03/04/2021

Event Type  Injury  

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 Description

A (b)(6) 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 70 mm male-female midsection that was placed during the primary surgery, which took place on (b)(6) 2020, was explanted, and replaced with a 60 mm male-female midsection.This was done to increase the range of motion of the knee.An 8 mm poly spacer was explanted during the revision which was placed during the primary surgery.This was replaced with a 12 mm poly spacer.During the revision, the distal femur component, tibial hinge component, and distal femur axial pin.

• Brand Name: ELEOS
• Type of Device: TIBIAL HINGE COMPONENT, W/ ROTATIONAL STOP
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 11603548
• MDR Text Key: 243410625
• Report Number: 3013450937-2021-00027
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825002100E0
• UDI-Public: B27825002100E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25002100E
• Device Catalogue Number: 25002100E
• Device Lot Number: 1825937
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR