MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; RESURFACING FEMUR AXIAL PIN

Lot Number 1921666

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Laxity (4526)

Event Date 01/25/2024

Event Type  Injury  

Event 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).

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
• Type of Device: RESURFACING FEMUR AXIAL PIN
• 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: 18630821
• MDR Text Key: 334432103
• Report Number: 3013450937-2024-00019
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001210E0
• UDI-Public: B27825001210E0
• 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: Physician
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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: ELEOS¿ RESURFACING FEMUR AXIAL PIN SIZE 4; ELEOS¿ TIBIAL HINGE W/ ROTATIONAL STOP ONE SIZE; ELEOS¿ TIBIAL POLY SPACER 10MM
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male