MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; FEMORAL HEAD

Lot Number	1973739
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on available information, including details reported by an onkos sales representative, the probable root cause of the dislocation is an incorrect selection of articulating devices which interface at the hip joint.The root cause of the hip joint dislocation was not related to the design, manufacture, and/or sterilization of the implant.
Event or Problem Description
This retrospective report was opened to investigate a previously unreported revision surgery.This revision was discovered during the investigation of pcr 03192024-1 which involves the same patient in a later revision.Information was obtained about this surgery through a phone call with s.Bivens, an onkos distributor.He reported that the 42-year-old female patient with an eleos total femur replacement underwent a revision surgery on (b)(6) 2024 to replace an eleos femoral head due to dislocation at the hip joint.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: FEMORAL HEAD
• 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
• MDR Report Key: 19072364
• Report Number: 3013450937-2024-00086
• Device Sequence Number: 14623317
• Product Code: KRO
• UDI-Device Identifier: B27826012802E0
• UDI-Public: B27826012802E0
• 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: 2024
• 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: 1973739
• 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: 03/27/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2023
• 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: 42 YR
• Patient Sex: Female