MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; DISTAL FEMUR AXIAL PIN

Model Number 25002111E

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Unspecified Tissue Injury (4559)

Event Date 09/28/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision surgery on (b)(6) 2021.The patient fell for an unknown reason which caused soft tissue damage to the surrounding structures of the knee.During the revision surgery, the surgeon performed a soft tissue repair.A segmental stem was requested for the revision surgery but was not implanted.No eleos implants were revised during the revision surgery.No additional information regarding this adverse event has been made available.

Manufacturer Narrative

Additional information regarding this adverse event was received on (b)(6) 2021 and the investigation was concluded on (b)(6) 2021.The patient suffered a fall due to an unknown reason which caused soft tissue damage.The surgeon performed a soft tissue repair during the surgery and did not revise any of the eleos implants.The device was not returned for evaluation.The root cause of the patient's fall could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that could have contributed to this complaint.If any additional information is obtained, a supplemental mdr will be filed accordingly.Multiple mdr reports were submitted for this event: #3013450937-2021-00234, #3013450937-2021-00235, #3013450937-2021-00236, #3013450937-2021-00322, #3013450937-2021-00323, #3013450937-2021-00324, #3013450937-2021-00325, #3013450937-2021-00326, #3013450937-2021-00327.

• Brand Name: ELEOS
• Type of Device: DISTAL FEMUR AXIAL PIN
• 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: 13011515
• MDR Text Key: 287685168
• Report Number: 3013450937-2021-00321
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825002111E0
• UDI-Public: +B27825002111E0
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25002111E
• Device Catalogue Number: 25002111E
• Device Lot Number: 1872103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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 25001050E, ELEOS MALE-FEMALE MIDSECTION 50MM.; P/N 25001070E, ELEOS MALE-FEMALE MIDSECTION 70MM.; P/N 25001208E, ELEOS TIBIAL POLY SPACER.; P/N 25002204E, ELEOS TIBIAL BASEPLATE.; P/N HC-13120-03M, ELEOS CEMENTED SEGMENTAL STEM.; P/N HR-30000-03M ELEOS MODULAR COLLAR LOCKING RING.; P/N PB-2400R-03M, ELEOS BIOGRIP COLLAR.; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 19 YR
• Patient Sex: Male