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

Lot Number	1921666
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 05 january 2024, b.Steinkamp (an onkos distributor) reported that a 77-year-old male patient who had allegedly suffered from instability in the knee joint involving a previously implanted eleos hinge knee replacement, underwent a revision surgery to replace the 10mm tibial poly spacer with a 20mm tibial poly spacer.The following eleos implants were also replaced as part of this revision: tibial hinge w/ rotational stop and resurfacing femur axial pin.The revision surgery was performed by dr.(b)(6).
Additional Manufacturer Narrative
On 05 january 2024, b.Steinkamp (an onkos distributor) reported that a 77-year-old male patient who had allegedly suffered from instability in the knee joint involving a previously implanted eleos hinge knee replacement, underwent a revision surgery to replace the 10mm tibial poly spacer with a 20mm tibial poly spacer.All inspection and manufacturing data was reviewed for the revised eleos implants; the lots were found to be conforming to specifications and no manufacturing abnormalities were observed.As detailed in section 3.5, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that represent potential contributing factors to the adverse effect(s) identified in this complaint.The root cause of this complaint was not determined.Based on the review of device history records, the investigation concluded that the root cause of the knee joint instability was not related to the design, manufacture, and/or sterilization of the revised eleos implants.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: TIBIAL HINGE W/ ROTATIONAL STOP
• 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 07054
• MDR Report Key: 18630733
• Report Number: 3013450937-2024-00020
• Device Sequence Number: 7732148
• Product Code: KRO
• UDI-Device Identifier: B27825001210E0
• UDI-Public: B27825001210E0
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2024

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
• Device Lot Number: 1921666
• 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: Not provided
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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: ELEOS¿ RESURFACING FEMUR AXIAL PIN SIZE 4.; ELEOS¿ TIBIAL HINGE W/ ROTATIONAL STOP ONE SIZE.; ELEOS¿ TIBIAL POLY SPACER 10MM.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male