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

Model Number THSMWRS01M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/29/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: 3013450937-2022-00142, 3013450937-2022-00143, 3013450937-2022-00144, 3013450937-2022-00145, 3013450937-2022-00146, 3013450937-2022-00147, 3013450937-2022-00148, 3013450937-2022-00149, 3013450937-2022-00151.

Event Description

It was reported that the patient developed an alleged infection.The patient underwent a revision surgery to washout their proximal femoral replacement system.The patient underwent another revision surgery to washout their distal femoral replacement system and revise the tibial hinge component, poly spacer, and distal femur axial pin.The patient underwent another revision surgery where all implants were revised.The following implants were revised: male-male midsection, male-female midsection, poly spacer, tibial hinge component, distal femur axial pin, proximal femur, and distal femur.No additional information regarding this adverse event has been reported.

Event Description

It was reported that the patient developed an alleged infection.The patient underwent a revision surgery to washout their proximal femoral replacement system.The patient underwent another revision surgery to washout their distal femoral replacement system and revise the tibial hinge component, poly spacer, and distal femur axial pin.The patient underwent another revision surgery where all implants were revised.The following implants were revised: male-male midsection, male-female midsection, poly spacer, tibial hinge component, distal femur axial pin, proximal femur, and distal femur.No additional information regarding this adverse event has been reported.

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: 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
• Type of Device: TIBIAL HINGE COMPONENT 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: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 14229174
• MDR Text Key: 290264417
• Report Number: 3013450937-2022-00150
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278THSMWRS01M0
• UDI-Public: B278THSMWRS01M0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: THSMWRS01M
• Device Catalogue Number: THSMWRS01M
• Device Lot Number: 1907564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: P/N 25000001E, ELEOS PROXIMAL FEMUR.; P/N 25000007E, ELEOS DISTAL FEMUR.; P/N 25000051E, ELEOS MALE-MALE MIDSECTION.; P/N 25001140E, ELEOS MALE FEMALE MIDSECTION.; P/N 25001210E, ELEOS POLY SPACER.; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female