MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; RESURFACING FEMUR AXIAL PIN, SIZE 4

Model Number	25002114E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation.The investigation is in progress.When the investigation is complete, a supplemental report will be submitted accordingly.Multiple mdrs were reported for this event: #3013450937-2021-00175, #3013450937-2021-00176, #3013450937-2021-00177, #3013450937-2021-00178, #3013450937-2021-00179, #3013450937-2021-00180, #3013450937-2021-00182, #3013450937-2021-00183.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The following parts were removed and revised: resurfacing femur axial pin, tibial hinge component, tibial poly spacer.The following parts remain implanted from the original eleos surgery which took place on (b)(6) 2021: 2 tibial block augments, resurfacing femur, cemented stem extension (18mm x 100mm), cemented stem extension (16mm x 65mm), and tibial baseplate.The surgeon performed a washout and administered antibiotics.No further information 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.The following parts were removed and revised: resurfacing femur axial pin, tibial hinge component, tibial poly spacer.The following parts remain implanted from the original eleos surgery which took place on (b)(6) 2021: 2 tibial block augments, resurfacing femur, cemented stem extension (18mm x 100mm), cemented stem extension (16mm x 65mm), and tibial baseplate.The surgeon performed a washout and administered antibiotics.No further information was 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 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.

• Brand Name: ELEOS
• Common Device Name: RESURFACING FEMUR AXIAL PIN, SIZE 4
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsipanny NJ 07054
• MDR Report Key: 12388337
• Report Number: 3013450937-2021-00181
• Device Sequence Number: 11061378
• Product Code: KRO
• UDI-Device Identifier: B27825002114E0
• UDI-Public: +B27825002114E0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/28/2021

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: 25002114E
• Device Catalogue Number: 25002114E
• Device Lot Number: 1860081
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/28/2021
• 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 25001212E, ELEOS TIBIAL POLY SPACER; P/N 25002205E, ELEOS TIBIAL BASEPLATE; P/N 2500R004E, ELEOS RESURFACING FEMUR; P/N KSC01665E, ELEOS CEMENTED STEM EXTENSION; P/N KSC18100E, ELEOS CEMENTED STEM EXTENSION; P/N KTAGB510E, ELEOS TIBIAL BLOCK AUGMENT; P/N KTAGB510E, ELEOS TIBIAL BLOCK AUGMENT; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT; PALACOS BONE CEMENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR