MAUDE Adverse Event Report: ONKOS SURGICAL INC. ELEOS LIMB SALVAGE SYSTEM; ELEOS PROXIMAL FEMUR, RIGHT

Catalog Number	PF-2000R-02M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is 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 for this event: 3013450937-2023-00225.
Event or Problem Description
It was reported on 05 september 2023 that a patient underwent a revision surgery on (b)(6) 2023, due to a potential infection.The patient was implanted with the eleos proximal femur system.During the revision procedure, the eleos proximal femur and eleos male-female midsection were removed and replaced.The patient's original surgery date is not known at this time; therefore, device specific information is not known.This event will be reportable to the fda as a serious injury due to the revision procedure, this report captures the eleos proximal femur.
Additional Manufacturer Narrative
It was reported that the patient developed an alleged infection and underwent a proximal femur revision surgery.Patient's original surgery date is unknown; therefore, device information could not be determined.Ultimately, the root cause of the patient's infection was unable to be determined.A review of the work order and sterilization batch release record for the product involved could not be performed as the product information is unknown.However, device history records are reviewed prior to releasing products to the field to verify that the products have been manufactured to the required specifications, as well as inspected to ensure compliance with their engineering drawing.If additional information is received regarding this event, this complaint will be updated accordingly.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: ELEOS PROXIMAL FEMUR, RIGHT
• Manufacturer (Section D): ONKOS SURGICAL INC.; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: vandita patel ; 77 e halsey road; parsippany, NJ 07054
• MDR Report Key: 17877570
• Report Number: 3013450937-2023-00224
• Device Sequence Number: 14549587
• Product Code: LPH
• UDI-Device Identifier: B278PF2000R02M0
• UDI-Public: B278PF2000R02M0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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 Catalogue Number: PF-2000R-02M
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown