MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS TIBIAL POLY SPACER; PROSTHESIS, KNEE

Model Number 25001216E

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Arthritis (1723)

Event Date 02/14/2018

Event Type  Injury  

Manufacturer Narrative

This medical device report (mdr) was initiated as part of a retrospective assessment of complaints under onkos surgical capa (b)(4).As part of this assessment, onkos surgical re-evaluated all complaints received to ensure mdrs were filed when required.The results of this retrospective assessment prompted onkos surgical to file this report.The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The operation notes were provided for review, which confirmed the adverse event.From the available information it was determined that the adverse event was not related to the manufacture of the implants or a non-conformance and this complaint has been closed.Should additional information be obtained the report will be supplemented.

Event Description

The patient underwent a right total knee arthroplasty due to instability, chronic subluxation of the patella, and severe arthrofibrosis.

• Brand Name: ELEOS TIBIAL POLY SPACER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDIC; 5677 airline road; arlington TN 38002
• Manufacturer Contact: cristina butrico ; 77 east halsey road; parsippany, NJ 07054 ; 9732645433
• MDR Report Key: 7868845
• MDR Text Key: 119969343
• Report Number: 3013450937-2018-00063
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001216E0
• UDI-Public: B27825001216E0
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25001216E
• Device Catalogue Number: 25001216E
• Device Lot Number: 1699788
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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): Required Intervention
• Patient Age: 41 YR