MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 12MM

Model Number	25001212E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	10/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed an alleged wound infection and underwent a revision surgery on (b)(6) 2021.During the revision surgery, the following eleos implants were revised: tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's original surgery: distal femur, male-female midsection, cemented stem extension, tibial baseplate, and cemented segmental stem.The surgeon performed a washout.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
The investigation is in process.Once the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs have been submitted for this adverse event: #3013450937-2021-00301, #3013450937-2021-00302, #3013450937-2021-00304, #3013450937-2021-00305, #3013450937-2021-00306, #3013450937-2021-00307, #3013450937-2021-00308.
Event or Problem Description
It was reported that the patient developed an alleged wound infection and underwent a revision surgery on (b)(6) 2021.During the revision surgery, the following eleos implants were revised: tibial hinge component, distal femur axial pin, and tibial poly spacer.The following eleos implants remain implanted from the patient's original surgery: distal femur, male-female midsection, cemented stem extension, tibial baseplate, and cemented segmental stem.The surgeon performed a washout.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged infection could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.

• Brand Name: ELEOS
• Common Device Name: TIBIAL POLY SPACER, 12MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 12870525
• Report Number: 3013450937-2021-00303
• Device Sequence Number: 6025065
• Product Code: KRO
• UDI-Device Identifier: B27825001212E0
• UDI-Public: B27825001212E0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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: 06/05/2026
• Device Model Number: 25001212E
• Device Catalogue Number: 25001212E
• Device Lot Number: 1751057
• 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: 10/29/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2018
• 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 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N CS-15120-03M, ELEOS CEMENTED SEGMENTAL STEM; P/N KSC01265E, ELEOS CEMENTED STEM EXTENSION; P/N TB-2202E-01M, ELEOS TIBIAL BASEPLATE; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female