MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ELEOS DISTAL FEMUR AXIAL PIN

Lot Number	1936787
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Additional 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) 3013450937-2023-00304.3013450937-2023-00306.
Event or Problem Description
Patient fell and dislocated.Dr.(b)(6) went in relocated the prosthesis and replaced the poly, axial pin and tibial hinge component.
Additional Manufacturer Narrative
It was reported by b.Steinkamp (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.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; 3013450937-2023-00306.
Event or Problem Description
It was reported by b.Steinkamp (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.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS DISTAL FEMUR AXIAL PIN
• 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: 18322645
• Report Number: 3013450937-2023-00305
• Device Sequence Number: 7459833
• Product Code: KRO
• UDI-Device Identifier: B27825001220E0
• UDI-Public: B27825001220E0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: 1936787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIZE 3 DISTAL FEMUR AXIAL PIN - 25002113E; TIBIAL HINGE WITH ROTATIONAL STOP - THSMWRS01M; TIBIAL POLY SPACER 20 MM - 25001220E
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male