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

Model Number 2500R004E

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

Patient Problem Unspecified Infection (1930)

Event Date 12/06/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2021-00346, #3013450937-2021-00347, #3013450937-2021-00349, #3013450937-2021-00350, #3013450937-2021-00351, #3013450937-2021-00352, #3013450937-2021-00353.

Event Description

It was reported that the patient developed an alleged infection and underwent a revision surgery on (b)(6) 2021.During the revision surgery, all of the eleos implants were explanted and a stryker intercalary system was placed.The following eleos implants were explanted on (b)(6) 2021: proximal tibia, poly spacer, tibial hinge component, canal-filling stem extension, resurfacing femur axial pin, segmental stem, resurfacing femur, and resurfacing patella.No additional information regarding this adverse event has been provided.

Event Description

It was reported that the patient developed an alleged infection and underwent a revision surgery on (b)(6) 2021.During the revision surgery, all of the eleos implants were explanted and a stryker intercalary system was placed.The following eleos implants were explanted on (b)(6) 2021: proximal tibia, poly spacer, tibial hinge component, canal-filling stem extension, resurfacing femur axial pin, segmental stem, resurfacing femur, and resurfacing patella.No additional information regarding this adverse event has been provided.

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.The following section was corrected: d10: concomitant medical products corrected.

• Brand Name: ELEOS
• Type of Device: RESURFACING FEMUR, SIZE 4, RIGHT
• 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: 13115761
• MDR Text Key: 282963900
• Report Number: 3013450937-2021-00348
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B2782500R004E0
• UDI-Public: B2782500R004E0
• 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: 02/28/2022

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
• Device Operator: Health Professional
• Device Model Number: 2500R004E
• Device Catalogue Number: 2500R004E
• Device Lot Number: 1710618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 02/27/2022
• Supplement Dates FDA Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2017
• 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 25001220E, ELEOS TIBIAL POLY SPACER; P/N 25001220E, ELEOS TIBIAL POLY SPACER; P/N 25002101E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002114E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N 25002114E, ELEOS RESURFACING FEMUR AXIAL PIN; P/N FS-15120-03M, ELEOS CANAL-FILLING STEM; P/N FS-15120-03M, ELEOS SEGMENTAL STEM; P/N KPONTP32E, ELEOS RESURFACING PATELLA; P/N KPONTP32E, ELEOS RESURFACING PATELLA; P/N KSP12140E, ELEOS CANAL-FILLING STEM EXTENSION; P/N KSP12140E, ELEOS STEM EXTENSION; P/N PT-20000-02M, ELEOS PROXIMAL TIBIA; P/N PT-20000-02M, ELEOS PROXIMAL TIBIA; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male