MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; MALE-FEMALE MIDSECTION

Catalog Number	25001040E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation for this event is currently in process.Once additional information is received, a supplemental will be filed accordingly.The following mfrs were submitted for this event: 3013450937-2024-00108.3013450937-2024-00109.
Event or Problem Description
The patient is currently implanted with an eleos distal femoral replacement.It was reported that a patient is experiencing a limited range of motion.The patient will be undergoing a revision procedure to replace the current eleos midsection and eleos distal femur to shorter sizes, in order to decrease the length of the construct.This event will be reportable to the fda as a serious injury as the patient will be revised to replace the implanted devices.This report will cover the eleos midsection.
Additional Manufacturer Narrative
The patient is currently implanted with an eleos distal femoral replacement.It was reported that a patient is experiencing a limited range of motion.The patient will be undergoing a revision procedure to replace the current eleos midsection and eleos distal femur to shorter sizes, in order to decrease the length of the construct.The device history records and historical trend data were reviewed and no abnormalities were identified.The eleos limb salvage system surgical technique advises to trial and perform trial reduction if required, to allow for proper patella tracking and range of motion.Additionally, the eleos limb salvage system ifu advises that correct selection of prosthesis is reliant on the judgement of the medical professional.Based on the available information, the cause could not be determined conclusively.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: MALE-FEMALE MIDSECTION
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07652
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 19130564
• Report Number: 3013450937-2024-00108
• Device Sequence Number: 12487807
• Product Code: KRO
• UDI-Device Identifier: B27825001040E0
• UDI-Public: B27825001040E0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/25/2024

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 Catalogue Number: 25001040E
• Device Lot Number: 1907572
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Female