MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 10MM

Model Number 25001210E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

The root cause for the infection was unable to be determined.It was reported by the sales representative that the amputation of the patient's limb was the patient's choice and the patient could have opted for a revision surgery to address the infection without amputation.The patient's medical history is unknown.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 sterilization of the implants or a nonconformance.

Event Description

A patient underwent an amputation surgery performed by dr.(b)(6) on (b)(6) 2020 due to an alleged infection of eleos components.Instead of revision, the patient opted for amputation of the limb above the knee.The patient underwent his primary eleos surgery on (b)(6) 2019 where he underwent a revision of a total knee arthroplasty.The following implants were placed during the primary eleos surgery, and were removed during the amputation surgery: a tibial baseplate, two tibial block augments, two cemented stem extensions, a resurfacing femur, a resurfacing femur axial pin, a tibial hinge component, and a tibial poly spacer.

• Brand Name: ELEOS
• Type of Device: TIBIAL POLY SPACER, 10MM
• 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: 11015763
• MDR Text Key: 222068482
• Report Number: 3013450937-2020-00190
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001210E0
• UDI-Public: B27825001210E0
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001210E
• Device Catalogue Number: 25001210E
• Device Lot Number: 1734497
• Date Manufacturer Received: 11/19/2020
• 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: 68 YR