MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL HINGE W/ ROTATIONAL STOP

Model Number	THSMWOS01M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced an infection and underwent a revision surgery.The following implants were removed and replaced during the revision: eleos tibial hinge, eleos tibial poly spacer, eleos distal femur axial pin, eleos distal femur and 2 x eleos male-female midsections.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this adverse event: 3013450937-2022-00202, 3013450937-2022-00203, 3013450937-2022-00204, 3013450937-2022-00206, 3013450937-2022-00207, 3013450937-2022-00208, 3013450937-2022-00209, 3013450937-2022-00210, 3013450937-2022-00211, 3013450937-2022-00212 and 3013450937-2022-00213.
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.The following sections were updated: 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 a patient experienced an infection and underwent a revision surgery.The following implants were removed and replaced during the revision: eleos tibial hinge component, eleos tibial poly spacer, eleos distal femur axial pin, eleos distal femur, and two eleos male-female midsections.The following eleos implants remain implanted from the patient's original surgery: cemented segmental stem, biogrip modular collar, collar locking ring, tibial baseplate, canal-filling stem extension, and tibial baseplate screw.No additional information regarding this adverse event has been provided.

• Brand Name: ELEOS
• Common Device Name: TIBIAL HINGE W/ ROTATIONAL STOP
• 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: danielle pierce ; 77 east halsey road; parsippany 07054 ; 8447672766
• MDR Report Key: 15079957
• Report Number: 3013450937-2022-00205
• Device Sequence Number: 3978249
• Product Code: KRO
• UDI-Device Identifier: B278THSMWOS01M0
• UDI-Public: B278THSMWOS01M0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K203815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 10/18/2022

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 Model Number: THSMWOS01M
• Device Catalogue Number: THSMWOS01M
• Device Lot Number: 1885121
• 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: 06/21/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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: 25000009E ELEOS DISTAL FEMUR, RIGHT, SEGMENTAL; 25001040E ELEOS MALE-FEMALE MIDSECTION 40MM; 25001040E ELEOS MALE-FEMALE MIDSECTION 40MM; 25001208E ELEOS TIBIAL POLY SPACER 8MM; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; HC-15120-03M ELEOS CEMENTED SEGMENTAL STEM; HR-30001-03M ELEOS LOCKING RING & IMPACTOR TIP; KSP15100E ELEOS STEM EXTENSION CANAL FILLING; PB-3200R-03M ELEOS MODULAR POROUS BIOGRIP COLLAR; TB-2204E-01M TIBIAL BASEPLATE SIZE 4; TB-TSCRW-01M ELEOS TIBIAL BASEPLATE TAPERED SCREW
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male