MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM CANAL FILLING; PROSTHESIS, KNEE

Model Number	KSP14140E
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The explanted component was unable to be returned for further analysis.Through interviews with the sales representative it was revealed that during the previous surgery an intramedullary reamer perforated the tibia, which may have contributed to this adverse event.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient underwent a revision surgery due to a stem perforating the tibia.

• Brand Name: ELEOS SEGMENTAL STEM CANAL FILLING
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 9565642
• Report Number: 3013450937-2020-00001
• Device Sequence Number: 11334485
• Product Code: KRO
• UDI-Device Identifier: B278KSP14140E0
• UDI-Public: B278KSP14140E0
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2025
• Device Model Number: KSP14140E
• Device Catalogue Number: KSP14140E
• Device Lot Number: 1714676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR