MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 50MM

Model Number	25001050E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Unspecified Tissue Injury (4559)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information regarding this adverse event was received on 19 november 2021 and the investigation was concluded on 15 december 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, #3013450937-2021-00321, #3013450937-2021-00322, #3013450937-2021-00323, #3013450937-2021-00325, #3013450937-2021-00326, #3013450937-2021-00327.
Event or Problem 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.

• Brand Name: ELEOS
• Common Device Name: MALE-FEMALE MIDSECTION, 50MM
• 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: 13011501
• Report Number: 3013450937-2021-00324
• Device Sequence Number: 4952267
• Product Code: KRO
• UDI-Device Identifier: B27825001050E0
• UDI-Public: +B27825001050E0
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2025
• Device Model Number: 25001050E
• Device Catalogue Number: 25001050E
• Device Lot Number: 1699747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001070E, ELEOS MALE-FEMALE MIDSECTION 70MM; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 19 YR
• Patient Sex: Male