MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; TIBIAL ROTATIONAL HINGE

Model Number THSMWRS01M

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2024

Event Type  Injury  

Manufacturer Narrative

The revision surgery investigated via the current report occurred on (b)(6) 2023.At the time of the revision surgery, the then 47-year-old female patient was implanted with eleos devices matching the part numbers identified in the table above.The explanted device information is unknown.No additional patient information or surgical details were identified through a review of historical records with respect to the surgeons that are known to have operated on the patient or the facilities in which the patient underwent known revision surgeries.A request for information was sent via email on 08 march 2024 to the appropriate onkos rsm and distributor; no additional information was able to be provided.This retrospective investigation was unable to confirm specific surgical details, including the purpose of the revision surgery.It is not known if there were any onkos devices explanted or if they were of the same part number as the devices implanted during the revision surgery.The devices identified in the table of section 1.0 are provided solely as a reference and reflects the devices implanted on (b)(6) 2023.The root cause of the adverse event could not be determined because the failure mode and general purpose of the revision surgery could not be confirmed.In addition, the part number and lot number of explanted devices remains unknown.Mdrs will be submitted to the fda out of an abundance of caution, based upon a reasonable assumption that the devices explanted during the revision surgery were provided by onkos and contained identical part numbers as the devices that were implanted at the time.The following mdrs are submitted as part of this adverse event investigation: 3013450937-2024-00063 3013450937-2024-00064 3013450937-2024-00065 3013450937-2024-00066 3013450937-2024-00067 3013450937-2024-00068.

Event Description

The revision surgery investigated via the current report occurred on (b)(6) 2023.At the time of the revision surgery, the then 47-year-old female patient was implanted with eleos devices matching the part numbers identified in the table above.The explanted device information is unknown.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: TIBIAL ROTATIONAL HINGE
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer Contact: yara neurauter ; 77 east halsey road; parsippany, NJ 07054 ; 8447672766
• MDR Report Key: 18906039
• MDR Text Key: 337689673
• Report Number: 3013450937-2024-00068
• 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
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: THSMWRS01M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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: CEMENTED SEGMENTAL STEM; DISTAL FEMUR; DISTAL FEMUR AXIAL PIN; POLY SPACER; RESURFACING PATELLA; TIBIAL ROTATIONAL HINGE
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female