MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; PROXIMAL FEMUR, RIGHT, 98MM

Model Number	PF-2000R-02M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was received on 03 feb 2023, which identified the devices involved in this adverse event.Therefore, this report is being submitted to capture the investigation of the devices involved in this adverse event.The device was not returned for evaluation.The root cause of the alleged infection could not be determined.Review of the device history records and sterilization batch records did not reveal any non-conformances that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.Multiple mdrs were submitted for this adverse event: 3013450937-2021-00061.3013450937-2023-00028.3013450937-2023-00029.3013450937-2023-00030.3013450937-2023-00031.3013450937-2023-00032.3013450937-2023-00034.3013450937-2023-00035.3013450937-2023-00036.3013450937-2023-00037.
Event or Problem Description
It was reported that the patient was revised on (b)(6) 2021 due to an alleged infection.During this revision surgery the following implants were revised: eleos tibial hinge component, eleos tibial poly spacer, eleos distal femur axial pin and eleos distal femur.The following eleos implants remain implanted from the patient's original surgery: canal-filling stem extension, tibial baseplate, male-female midsections, male-male midsection, and proximal femur.No additional information regarding this adverse event has been reported.

• Brand Name: ELEOS
• Common Device Name: PROXIMAL FEMUR, RIGHT, 98MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 16482876
• Report Number: 3013450937-2023-00033
• Device Sequence Number: 7774738
• Product Code: JDI
• UDI-Device Identifier: B278PF2000R02M0
• UDI-Public: B278PF2000R02M0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2023

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 Model Number: PF-2000R-02M
• Device Catalogue Number: PF-2000R-02M
• Device Lot Number: 87947-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001070E, ELEOS MALE FEMALE MIDSECTION; P/N 25001090E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001110E, ELEOS MALE FEMALE MIDSECTION; P/N 25001208E, ELEOS POLY SPACER; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002205E, ELEOS TIBIAL BASEPLATE; P/N KSP13140E, ELEOS STEM EXTENSION; P/N MS-070MM-02M, ELEOS MALE-MALE MIDSECTION
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 24 YR
• Patient Sex: Male