MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL BASEPLATE, SIZE 2

Model Number	25002202E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation as it remains implanted.The investigation is in progress.When the investigation is complete, a supplemental report will be submitted accordingly.Multiple mdrs were reported for this event: #3013450937-2021-00125.#3013450937-2021-00127.#3013450937-2021-00128.#3013450937-2021-00129.#3013450937-2021-00130.#3013450937-2021-00131.#3013450937-2021-00132.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The patient developed an alleged infection with unknown implants that were implanted on (b)(6) 2019 for an unknown reason.The patient underwent a first stage revision surgery on (b)(6) 2019 where the following eleos parts were implanted: tibial hinge component with rotational stop, tibial baseplate, stem extension, distal femur, tibial block augment, distal femur axial pin, segmental stem, and tibial poly spacer.The second stage revision surgery took place on (b)(6) 2021 where the following eleos components were removed and replaced: tibial hinge component, distal femur axial pin, and tibial poly spacer.A washout was performed and additional antibiotics were inserted.The following eleos components are still implanted: tibial baseplate, stem extension, distal femur, tibial block augment, and segmental stem.No additional information regarding this event has been made available.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The patient developed an alleged infection with smith & nephew implants that were implanted on (b)(6) 2019 for an unknown reason.The patient underwent a first stage revision surgery on (b)(6) 2019 where the following eleos parts were implanted: tibial hinge component with rotational stop, tibial baseplate, stem extension, distal femur, tibial block augment, distal femur axial pin, segmental stem, and tibial poly spacer.The second stage revision surgery took place on (b)(6) 2021 where the following eleos components were removed and replaced: tibial hinge component, distal femur axial pin, and tibial poly spacer.A washout was performed and additional antibiotics were inserted.The following eleos components are still implanted: tibial baseplate, stem extension, distal femur, tibial block augment, and segmental stem.No additional information regarding this event has been made available.
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 patient undergoing a revision surgery due to an 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 could have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added.B5: event description updated.G3: date received by manufacturer added.G6: type of report added.H6: type of investigation code updated to 3331: analysis of production records.H6: type of investigation code updated to 4111: communication/interviews.H6: type of investigation code updated to 4110: trend analysis.H6: type of investigation code updated to 4114: device not returned.H6: type of investigation code updated to 4117: device not accessible for testing.H6: type of investigation code updated to 4109: historical data analysis.H6: investigation findings code updated to 213: no device problem found.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.

• Brand Name: ELEOS
• Common Device Name: TIBIAL BASEPLATE, SIZE 2
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12099599
• Report Number: 3013450937-2021-00126
• Device Sequence Number: 3768784
• Product Code: KRO
• UDI-Device Identifier: B27825002202E0
• UDI-Public: B27825002202E0
• 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: 2019
• 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): 08/10/2021

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: 12/22/2025
• Device Model Number: 25002202E
• Device Catalogue Number: 25002202E
• Device Lot Number: 1727094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001210E, ELEOS TIBIAL POLY SPACER; P/N 25002100E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N CS-15120-03M, ELEOS SEGMENTAL STEM; P/N KSC01465E, ELEOS STEM EXTENSION, CEMENTED; P/N KTAGB210E, ELEOS TIBIAL BLOCK AUGMENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 87 YR