MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; CEMENTED SEGMENTAL STEM

Lot Number	82284
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 loosening in the cemented segmental stem was not related to the design, manufacture, and/or sterilization of the previously implanted eleos device.
Event or Problem Description
A revision surgery that occurred on (b)(6) 2024 was discovered during the investigation of an unrelated complaint.This complaint report was subsequently initiated to investigate.Information about the revision that took place on (b)(6) 2024 was provided by (b)(6), an onkos sales representative.(b)(6) reported that the 66-year-old female patient with an eleos proximal tibia and distal femur replacement underwent the revision surgery to address an alleged loosening of the femoral segmental stem.The cemented segmental stem was removed and replaced along with several other eleos devices that were components of the prosthetic construct.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: CEMENTED SEGMENTAL STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 19072732
• Report Number: 3013450937-2024-00087
• Device Sequence Number: 20558003
• Product Code: KRO
• UDI-Device Identifier: B278CB1515203M0
• UDI-Public: B278CB1515203M0
• Combination Product (Y/N): N
• 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: 2024
• 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
• Report Date (Section B): 04/09/2024

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
• Device Lot Number: 82284
• 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: 03/25/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female