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

Lot Number	90769-006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this adverse event, the patient had non-onkos femoral head and non-onkos total hip arthroplasty devices implanted.The root cause for the patient's hip dislocating was unable to be determined.Due to the surgeon's shortening of the limb during the revision, the limb length may have been a contributing factor to the hip dislocation.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
Event or Problem Description
It was reported by an onkos distributor that a 55-year-old female patient with an eleos total femur replacement required a revision surgery due to dislocation of the proximal femur from the non-onkos acetabular devices which resulted in dislocation of the tibial rotational hinge at the knee.The revision surgery was performed on (b)(6) 2024 at which point the surgeon manually relocated the knee joint.At the time of this adverse event, the patient had non-onkos femoral head and non-onkos total hip arthroplasty devices implanted.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: MALE-MALE 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
• MDR Report Key: 18989300
• Report Number: 3013450937-2024-00070
• Device Sequence Number: 12814275
• Product Code: KRO
• UDI-Device Identifier: B278MS070MM02M0
• UDI-Public: B278MS070MM02M0
• 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: 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): 03/27/2024

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: 90769-006
• 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: 03/20/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2021
• 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: DISTAL FEMUR AXIAL PIN; MALE-FEMALE MIDSECTION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female