MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM EXTENSION, 14X100MM, CEMENTED, STRAIGHT, FLUTED

Model Number KSP14100E

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2021

Event Type  Injury  

Manufacturer Narrative

The root cause for the femoral stem loosening is unknown.The patient's medical history is unknown.The patient's weight, bone density, and activity level are unknown and it is not known if any of these contributed to this failure.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 Description

A (b)(6) male patient underwent a revision surgery on (b)(6) 2021 performed by dr.(b)(6) due to aseptic loosening of the patient's femoral stem implant.The surgeon revised a resurfacing femur, a resurfacing femur axial pin, a tibial hinge component, and the femoral stem extension.It is unknown if the patient sustained a trauma that may have contributed to the failure.

• Brand Name: ELEOS
• Type of Device: STEM EXTENSION, 14X100MM, CEMENTED, STRAIGHT, FLUTED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 11683401
• MDR Text Key: 245975269
• Report Number: 3013450937-2021-00049
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KSP14100E
• Device Catalogue Number: KSP14100E
• Device Lot Number: 1790837
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 76 YR