MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; FEMORAL HEAD

Lot Number 1719308

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 335694618
• Report Number: 3013450937-2024-00028
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2024
• Date Device Manufactured: 07/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 72 KG