MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; FEMORAL HEAD

Lot Number	1719308
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by (b)(6) an onkos distributor, that a 60-year-old female patient with poor bone quality suffered from hip joint instability.The surgeon, doctor (b)(6), converted the hip joint to a total hip arthroplasty during the revision surgery on (b)(6) 2024.All inspection and manufacturing data was reviewed for lot# 1719308; the lot was found to be conforming to specifications and no manufacturing abnormalities were observed.As detailed in section 3.5, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that potentially contribute to adverse effects.The root cause of this complaint was not determined.
Event or Problem Description
It was reported by (b)(6) , an onkos distributor, that a 60-year-old female patient with poor bone quality suffered from hip joint instability.The surgeon, doctor (b)(6), converted the hip joint to a total hip arthroplasty during the revision surgery on (b)(6) 2024.

• Brand Name: ELEOS
• Common Device Name: FEMORAL HEAD
• 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: 18726875
• Report Number: 3013450937-2024-00028
• Device Sequence Number: 20230708
• Product Code: KRO
• UDI-Device Identifier: B27826012804E0
• UDI-Public: B27826012804E0
• 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 Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 1719308
• 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: 02/16/2024
• Date Device Manufactured: 07/27/2017
• 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: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 72 KG