MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS STEM EXTENSION

Model Number KSP11140E

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

The device history record and sterilization batch release record were reviewed and indicated that the component met specification.It can be concluded that the manufacturing of the implant was unlikely to cause the adverse event.The sales representative stated that the surgeon stated that the surgical tech most likely did not impact the stem into place hard enough.

Event Description

The patient's implanted tibial stem component loosened.

• Brand Name: ELEOS STEM EXTENSION
• Type of Device: ELEOS STEM EXTENSION
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington, tn
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, nj
• MDR Report Key: 10247970
• MDR Text Key: 198094140
• Report Number: 3013450937-2020-00102
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278KSP11140E0
• UDI-Public: B278KSP11140E0
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KSP11140E
• Device Catalogue Number: KSP11140E
• Device Lot Number: 1695384
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention