MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL BLOCK AUGMENT

Model Number	KTAGB405E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was discovered on (b)(6) 2022, through pcr (b)(4), that a patient underwent a prior revision surgery due to infection on (b)(6) 2021.The patient's index procedure occured on (b)(6) 2021.During the revision procedure, the eleos distal femur axial pin, eleos tibial poly spacer, and eleos tibial hinge w/ rotational stop were removed and replaced.The following devices remain implanted: eleos cemented straight segmental stem, eleos tibial block augment, eleos distal femur, eleos tibial baseplate, eleos male-female midsection.This event will be reported to the fda as a serious injury due to revision surgery.This record captures the eleos tibial block augment.
Additional Manufacturer Narrative
On 01 september 2022, it was discovered through pcr 08052022-1 that the patient underwent a prior revision surgery due to infection on (b)(6) 2021.This complaint was opened to capture the patients first revision surgery on (b)(6)2021.The eleos distal femur axial pin, eleos tibial poly spacer, and eleos tibial hinge w/ rotational stop were removed and replaced.The following devices remain implanted: eleos cemented straight segmental stem, eleos tibial block augment, eleos distal femur, eleos tibial baseplate, eleos male-female midsection.The patient's index surgery occurred on (b)(6)2021, where the patient underwent an eleos distal femoral replacement.On (b)(6) 2021 the patient was revised due to an alleged infection.During this revision procedure, the distal femur axial pin, the poly spacer, and the tibial hinge were removed and replaced.On (b)(6) 2022 the patient underwent a second revision procedure to remove and replace the poly spacer, which is captured in pcr 08052022-1.The cause for the patient's second revision procedure is not known.A review of the work orders and sterilization batch release records for the products involved found no indication that the alleged infection was a result of a manufacturing or sterilization nonconformance.The root cause identified for this complaint is an alleged infection, which required surgical intervention.The cause of the patient's alleged infection could not be determined.

• Brand Name: ELEOS
• Common Device Name: TIBIAL BLOCK AUGMENT
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsipanny NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline rd; arlington TN 38002
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsipanny, NJ 07054
• MDR Report Key: 15526012
• Report Number: 3013450937-2022-00284
• Device Sequence Number: 5990980
• Product Code: KRO
• UDI-Device Identifier: B278KTAGB405E0
• UDI-Public: B278KTAGB405E0
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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 Model Number: KTAGB405E
• Device Catalogue Number: KTAGB405E
• Device Lot Number: 1720593
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female