MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, 20MM

Model Number 25001220E

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

Patient Problem Joint Laxity (4526)

Event Date 07/25/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery on (b)(6) 2023 due to soft tissue laxity.During the revision surgery, the surgeon revised the distal femur axial pin, poly spacer, and tibial hinge component.No additional information regarding this adverse event has been reported.

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: #3013450937-2023-00167, #3013450937-2023-00168.The following mdrs were submitted for the same patient: #3013450937-2021-00270, #3013450937-2021-00271, #3013450937-2021-00272, #3013450937-2021-00273, #3013450937-2021-00274, #3013450937-2021-00275, #3013450937-2021-00276, #3013450937-2021-00277, #3013450937-2021-00278, #3013450937-2021-00279, #3013450937-2023-00060, #3013450937-2023-00061, #3013450937-2023-00062.

• Brand Name: ELEOS
• Type of Device: TIBIAL POLY SPACER, 20MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 17594882
• MDR Text Key: 321630348
• Report Number: 3013450937-2023-00169
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001220E0
• UDI-Public: B27825001220E0
• 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: 08/22/2023

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: 25001220E
• Device Catalogue Number: 25001220E
• Device Lot Number: 1880783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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 25001040E, ELEOS MALE FEMALE MIDSECTION; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002203E, ELEOS TIBIAL BASEPLATE; P/N 2500BP22E, ELEOS SEGMENTAL STEM; P/N KSP18140E, ELEOS STEM EXTENSION; P/N KTAGB305E, ELEOS TIBIAL BLOCK AUGMENT; P/N KTAGB315E, ELEOS TIBIAL BLOCK AUGMENT; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male