MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM PROXIMAL TIBIA WITH BIOGRIP

Model Number PT-20000-02M

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

Patient Problem Pain (1994)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

No additional information is available at this time. Once additional information is received, this record will be updated accordingly.

Event Description

It was reported that a patient underwent revision surgery on (b)(6) 2022 due to suture tearing post-operatively. The tibial tubercle was no longer attached to the eleos proximal tibia implant, causing the patient to experience anterior knee pain. During the revision procedure, the eleos tibial polyspacer, eleos tibial hinge, eleos resurfacing femur axial pin, and eleos proximal tibia were replaced. No specific device failures related to an onkos implant were reported. However, this event will be reported as a serious injury due to revision procedure. This record captures the eleos proximal tibia.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: PROXIMAL TIBIA WITH BIOGRIP
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 13840377
• MDR Text Key: 287549831
• Report Number: 3013450937-2022-00117
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PT-20000-02M
• Device Catalogue Number: PT-20000-02M
• Device Lot Number: 88658RR-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/21/2022 Patient Sequence Number: 1

Treatment

ELEOS CANAL FILLING STEM, P/N FS-14120-03M; ELEOS RESURFACING FEMUR AXIAL PIN, P/N 25002113E; ELEOS RESURFACING FEMUR, P/N 250L003E; ELEOS STEM EXTENSION, P/N KSP13140E; ELEOS TIBIAL HINGE, P/N THSMWRS01M; ELEOS TIBIAL POLYSPACER, P/N 25001208E