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

Lot Number	1887366
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the reported adverse event cannot be determined.There is no reported deficiency with the previously implanted eleos devices that remain implanted or were removed as part of the revision surgery.All inspection and manufacturing data was reviewed for the device lots listed in the table above; the lots were found to be conforming to specifications and no manufacturing abnormalities were observed.The following mdrs are related to this case: 3013450937-2024-00084.
Event or Problem Description
The patient with an eleos total femur replacement was reportedly revised due to a leg length discrepancy, requiring the operative leg to be shortened.P.Medina, an onkos sales representative, reported that a 50mm male-female midsection was removed and an 8mm poly spacer was replaced by a 16mm poly spacer during the revision surgery.All other explanted implants were swapped as part of the procedure.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: MALE-FEMALE MIDSECTION
• 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: 19038061
• Report Number: 3013450937-2024-00083
• Device Sequence Number: 15484020
• Product Code: KRO
• UDI-Device Identifier: B27825001050E0
• UDI-Public: B27825001050E0
• 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: 2022
• 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): 04/03/2024

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: 1887366
• 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: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 16MM TIBIAL POLY SPACER.; 50MM MALE-FEMALE MIDSECTION.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female