MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ELEOS TIBIAL POLYSPACER

Lot Number 1699712

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Joint Dislocation (2374)

Event Date 11/06/2023

Event Type  Injury  

Event Description

Patient fell and dislocated.Dr.(b)(6) went in relocated the prosthesis and replaced the poly, axial pin and tibial hinge component.

Manufacturer Narrative

The investigation in progress, additional information for this event is not known at this time, if additional information is received, a supplemental report will be submitted accordingly.The following mdrs were submitted (list out each component).3013450937-2023-00305.3013450937-2023-00306.

Event Description

It was reported by (b)(6) (an onkos distributor) that a 51-year-old male patient underwent a revision surgery to replace a dislocated eleos hinge knee replacement on (b)(6) 2023.The dislocation reportedly occurred due to the patient falling at which point the rotational hinge jumped the post.Doctor thompson was the surgeon for this revision surgery, which is the third revision surgery for this patient, based on the available information.The following eleos implants were replaced during the revision surgery: 20mm poly spacer, tibial hinge with rotational stop, and an eleos axial pin.

Manufacturer Narrative

It was reported by (b)(6) (an onkos distributor) that a 51-year-old male patient underwent a revision surgery to replace a dislocated eleos hinge knee replacement on (b)(6) 2023.The dislocation reportedly occurred due to the patient falling at which point the rotational hinge jumped the post.Doctor (b)(6) was the surgeon for this revision surgery, which is the third revision surgery for this patient, based on the available information.All inspection and manufacturing data was reviewed for the known revised eleos implants; the lots were found to be conforming to specifications and no manufacturing abnormalities were observed.As detailed in section 3.5, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that represent potential contributing factors to the adverse effect(s) identified in this complaint.The root cause of this complaint was not determined.Based on the review of device history records, the investigation concluded that the root cause of the tibial hinge dislocation was not related to the design, manufacture, and/or sterilization of the known revised eleos implants.The mdrs listed below are related to this adverse event.3013450937-2023-00304, 3013450937-2023-00305, 3013450937-2023-00306.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: ELEOS TIBIAL POLYSPACER
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsipanny NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsipanny NJ 07054
• Manufacturer Contact: vandita patel ; 77 east halsey road; parsipanny, NJ 07054
• MDR Report Key: 18322646
• MDR Text Key: 330428347
• Report Number: 3013450937-2023-00304
• Device Sequence Number: 1
• Product Code: KRO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 1699712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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
• Treatment: SIZE 3 DISTAL FEMUR AXIAL PIN - 25002113E; TIBIAL HINGE WITH ROTATIONAL STOP - THSMWRS01M; TIBIAL POLY SPACER 20 MM - 25001220E
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male