MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING STRAIGHT SEGMENTAL STEM, 20X120MM

Model Number FS-20120-03M

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

Patient Problems Fall (1848); Unspecified Infection (1930)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported that the patient fell and opened their incision.The patient underwent a revision surgery on (b)(6) 2022.The surgeon performed incision and drainage and revised the following implants: poly spacer, distal femur axial pin, and tibial hinge component.The following implants remain implanted from the patient's original surgery: distal femur, tibial baseplate, cemented stem extension, and canal-filling segmental stem.No additional information has been provided.

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: #3013450937-2022-00228, #3013450937-2022-00229, #3013450937-2022-00230, #3013450937-2022-00231, #3013450937-2022-00232, #3013450937-2022-00233.

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 fall and 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.

Event Description

It was reported that the patient fell and opened their incision.The patient underwent a revision surgery on (b)(6) 2022.The surgeon performed incision and drainage and revised the following implants: poly spacer, distal femur axial pin, and tibial hinge component.The following implants remain implanted from the patient's original surgery: distal femur, tibial baseplate, cemented stem extension, and canal-filling segmental stem.No additional information has been provided.

• Brand Name: ELEOS
• Type of Device: CANAL-FILLING STRAIGHT SEGMENTAL STEM, 20X120MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 15307889
• MDR Text Key: 298775130
• Report Number: 3013450937-2022-00234
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B278FS2012003M0
• UDI-Public: B278FS2012003M0
• 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: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FS-20120-03M
• Device Catalogue Number: FS-20120-03M
• Device Lot Number: 90723-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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 25000007E, ELEOS DISTAL FEMUR; P/N 25001210E, ELEOS POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N KSC16100E, ELEOS CEMENTED STEM EXTENSION; P/N TB-2203E-01M, ELEOS TIBIAL BASEPLATE; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female