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

Model Number	25001212E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation as it was discarded at the hospital.The investigation is in progress.When the investigation is complete, a supplemental report will be submitted accordingly.Multiple mdrs were reported for this event: # 3013450937-2021-00196, # 3013450937-2021-00197, # 3013450937-2021-00199, # 3013450937-2021-00200.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.During the revision surgery, the following implants were revised: eleos distal femur axial pin, eleos distal femur, eleos tibial poly spacer, eleos segmental stem, and eleos tibial hinge component.No further information regarding this event was 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.During the revision surgery, the following implants were revised: eleos distal femur axial pin, eleos distal femur, eleos tibial poly spacer, eleos segmental stem, and eleos tibial hinge component.Additional information was received that identified the following implants remain implanted from the patient's original eleos surgery: tibial baseplate, 2 tibial block augments, stem extension, and modular tibial base stem cap.Additional information regarding this event has not been provided.
Additional Manufacturer Narrative
This follow up report is being submitted to include additional information.The investigation is still ongoing and once it is concluded, a supplemental report will be submitted accordingly.The following fields were updated to add additional information: b4: date of this report added.B5: event description updated.B7: other relevant history added.D4: lot number added.D4: expiration date added.D6a: device implanted date added.D10: concomitant medical products added.G3: date received by manufacturer added.G6: type of report added.H2: follow up type added.H4: device manufacturer date added.H10: additional narrative/data.Multiple mdrs were reported for this event: #3013450937-2021-00196.#3013450937-2021-00197.#3013450937-2021-00199.#3013450937-2021-00200.#3013450937-2021-00223.#3013450937-2021-00224.#3013450937-2021-00225.#3013450937-2021-00226.#3013450937-2021-00227.
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 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.G3: date received by manufacturer added.G6: type of report added.H2: follow-up type added.H3: device evaluated by manufacturer updated to no.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.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.During the revision surgery, the following implants were revised: eleos distal femur axial pin, eleos distal femur, eleos tibial poly spacer, eleos segmental stem, and eleos tibial hinge component.Additional information was received that identified the following implants remain implanted from the patient's original eleos surgery: tibial baseplate, 2 tibial block augments, stem extension, and modular tibial base stem cap.Additional information regarding this event has not been provided.

• Brand Name: ELEOS
• Common Device Name: TIBIAL POLY SPACER, 12MM THICKNESS
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12454623
• Report Number: 3013450937-2021-00198
• Device Sequence Number: 17124536
• Product Code: KRO
• UDI-Device Identifier: B27825001212E0
• UDI-Public: +B27825001212E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/04/2021

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 Model Number: 25001212E
• Device Catalogue Number: 25001212E
• Device Lot Number: 1856902
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 09/28/2021; 11/04/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/05/2021; 11/04/2021
• 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 25000007E, ELEOS DISTAL FEMUR.; P/N 25000007E, ELEOS DISTAL FEMUR.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.; P/N 25002203E, ELEOS TIBIAL BASEPLATE.; P/N CS-13120-03M, ELEOS SEGMENTAL STEM.; P/N CS-17120-03M, ELEOS SEGMENTAL STEM.; P/N KSC01500E, ELEOS MODULAR TIBIAL BASE STEM CAP.; P/N KSC01530E, ELEOS STEM EXTENSION, CEMENTED.; P/N KTAGB305E, ELEOS TIBIAL BLOCK AUGMENT.; P/N KTAGB305E, ELEOS TIBIAL BLOCK AUGMENT.; P/N THSMWOS01M, ELEOS TIBIAL HINGE COMPONENT.; P/N THSMWOS01M, ELEOS TIBIAL HINGE COMPONENT.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR