MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM, CANAL FILLING, 16MM X 120MM, STRAIGHT, SPLINED, FULL PLASMA

Model Number 2500SP16E

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Scar Tissue (2060)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

The root cause for the failure was unable to be determined.The patient has undergone a previous revision surgery for the same issue.The patient's medical history is unknown, and it is unknown whether the patient sustained a trauma prior to the failure.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) male patient underwent a revision surgery on (b)(6) 2020 performed by dr.(b)(6) due to scar tissue forming around the patient's patella which was causing pain, stiffness, and a loss of range of motion of the knee.The surgeon debrided the scar tissue but did not replace the implants as they were deemed to not be affected and there were no failures found intraoperatively.

• Brand Name: ELEOS
• Type of Device: SEGMENTAL STEM, CANAL FILLING, 16MM X 120MM, STRAIGHT, SPLINED, FULL PLASMA
• 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: 10766324
• MDR Text Key: 214110116
• Report Number: 3013450937-2020-00165
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B2782500SP16E0
• UDI-Public: B2782500SP16E0
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2500SP16E
• Device Catalogue Number: 2500SP16E
• Device Lot Number: 1745568
• 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): Other; Required Intervention
• Patient Age: 39 YR