MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; TIBIAL POLY SPACER, THICKNESS 12MM

Model Number	25001212E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Mulitple mdrs were submitted for this adverse event: 3013450937-2023-00214, 3013450937-2023-00215, 3013450937-2023-00217, 3013450937-2023-00218 and 3013450937-2023-00219.The following mdrs were also submitted for this patient: 3013450937-2021-00150, 3013450937-2021-00151, 3013450937-2021-00152, 3013450937-2021-00153, 3013450937-2021-00154 and 3013450937-2021-00155.
Event or Problem Description
Patient was revised on (b)(6) 2023 for an alleged infection.During this revision surgery an antibiotic spacer was placed and the following implants were explanted: eleos resurfacing femur axial pin size: 3, eleos tibial hinge w/ rotational stop, eleos tibial poly spacer thickness 12mm, eleos resurfacing femur size: 3 right, eleos tibial baseplate size: 4, and eleos stem extension cemented 14x100mm.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
Patient underwent a revision surgery due to an infection.All implants were explanted, and an antibiotic spacer was placed.During the revision surgery the following eleos implants were removed: tibial hinge component w/ rotational stop (p/n thsmwrs01m), tibial poly spacer 12mm (p/n 25001212e), resurfacing femur axial pin, size 3 (p/n 25002113e), resurfacing femur, size 3 (p/n 2500r003e), stem extension, cemented, 14x100mm (p/n ksc14100e), and tibial baseplate, size 4 (p/n 25002204e).Visual inspection, dimensional inspection, functional inspection, and material analysis could not be performed as the products were not returned for evaluation.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 root cause of the patient's alleged infection could not be determined.Ultimately, based upon the device history records and sterilization records, the investigation concluded that the root cause of the alleged infection is not likely due to the design, manufacture, and/or sterilization of the components.

• Brand Name: ELEOS
• Common Device Name: TIBIAL POLY SPACER, THICKNESS 12MM
• 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: vandita patel ; 77 e halsey rd,; parsippany, NJ 07054 ; 9732645400
• MDR Report Key: 17848003
• Report Number: 3013450937-2023-00216
• Device Sequence Number: 14533241
• Product Code: KRO
• UDI-Device Identifier: B27825001212E0
• UDI-Public: B27825001212E0
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2023
• 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): 09/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: 25001212E
• Device Catalogue Number: 25001212E
• Device Lot Number: 1856902
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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: 25002113E ELEOS RESURFACING FEMUR AXIAL PIN SIZE3; 25002204E ELEOS TIBIAL BASEPLATE, SIZE: 4; 2500R003E ELEOS RESURFACING FEMUR, SIZE: 3, RIGHT; KSC14100E ELEOS STEM EXTENSION CEMENTED 14X100MM; THSMWRS01 ELEOS TIBIAL HINGE W/ ROTATIONAL STOP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male