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

Catalog Number	25001040E
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was identified that a patient received a revision procedure to remove and replace an eleos male-female midsection, eleos proximal femur, and an eleos male-female midsection.The reason for revision is unknown at this time.This event will be reportable to the fda as a serious injury due to the revision procedure.This report captures the first revised eleos male-female midsection.
Additional Manufacturer Narrative
Additional details are unknown at this time.If additional information is received, a supplemental report will be filed accordingly.
Event or Problem Description
It was identified that a patient received a revision procedure to remove and replace an eleos male-female midsection, eleos proximal femur, and an eleos male-female midsection.The patient was revised due to an alleged infection.This event will be reportable to the fda as a serious injury due to the revision procedure.This report captures the first revised eleos male-female midsection.
Additional Manufacturer Narrative
The patient's index surgery occurred on (b)(6) 2022.This complaint report investigates the patient's third revision procedure, which took place on (b)(6) 2023.During this procedure, the patient's proximal femur and two male-female midsections were replaced.Device history records and sterilization batch records were reviewed, and no abnormalities were identified.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 reported infection was not likely related to the design, manufacture, and/or sterilization of the revised eleos implants.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: MALE-FEMALE MIDSECTION
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 19325633
• Report Number: 3013450937-2024-00138
• Device Sequence Number: 6493424
• Product Code: KRO
• UDI-Device Identifier: B27825001040E0
• UDI-Public: B27825001040E0
• 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: 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): 08/06/2024

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: 1917740
• 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: 05/15/2023
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male