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

Model Number	SPSE0002E
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2019
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.Also, the revised implant was unable to be obtained for further analysis.Should additional information be obtained the report will be supplemented.
Event or Problem Description
The surgeon was unable to get a good fit with the segmental stem intraoperatively and a larger stem was placed.

• Brand Name: ELEOS SEGMENTAL STEM
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• MDR Report Key: 10906140
• Report Number: 3013450937-2020-00178
• Device Sequence Number: 3230211
• Product Code: KRO
• UDI-Device Identifier: B278SPSE0002E0
• UDI-Public: B278SPSE0002E0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

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: 03/16/2025
• Device Model Number: SPSE0002E
• Device Catalogue Number: SPSE0002E
• Device Lot Number: 1703434
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/25/2020
• 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: 12 YR