MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS CANAL FILLING STEM 12X100MM

Lot Number 1695383

Device Problem Insufficient Information (3190)

Patient Problem Arthralgia (2355)

Event Date 11/02/2023

Event Type  Injury  

Event Description

Patient underwent revision surgery for painful knee.During the revision surgery the following implants were explanted: size 3, resurfacing axial pin, size 3, resurfacing femur, tibial hinge with rotational stop, and canal filling stem 12x 100mm.The date and facility of the original surgery is unknown.

Manufacturer Narrative

The investigation is in process.The device will not be returned for evaluation.When the investigation is complete, a supplemental mdr will be submitted accordingly.The following mdrs have also been submitted for this patient: #3013450937-2023-00299; #3013450937-2023-00300; #3013450937-2023-00301.

Manufacturer Narrative

On (b)(6) 2023, (b)(6) reported that a 68-year-old male patient who had allegedly suffered from knee pain, underwent a revision surgery to replace the eleos distal femur replacement with larger-sized resurfacing femur, axial pin, and cemented stem extension.All inspection and manufacturing data was reviewed for revised eleos implants; the lots were found to be conforming to specifications and no manufacturing abnormalities were observed.As detailed in section 3.5 of the complaint report, the ifu and surgical technique documentation identifies elements such as patient contraindications, patient selection factors, surgical procedures/techniques and other precautions/conditions that may contribute to adverse effects.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 pain was not related to the design, manufacture, and/or sterilization of previously implanted eleos implants.The mdrs listed below are related to this report.3013450937-2023-00299; 3013450937-2023-00300; 3013450937-2023-00301; 3013450937-2023-00302.

Event Description

On (b)(6) 2023, (b)(6) reported that a 68-year-old male patient who had allegedly suffered from knee pain, underwent a revision surgery to replace the eleos distal femur replacement with larger-sized resurfacing femur, axial pin, and cemented stem extension.

• Brand Name: ELEOS
• Type of Device: ELEOS CANAL FILLING STEM 12X100MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsipanny NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: vandita patel ; 77 east halsey road; parsipanny, NJ 07054
• MDR Report Key: 18245810
• MDR Text Key: 329477684
• Report Number: 3013450937-2023-00302
• Device Sequence Number: 1
• Product Code: KRO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 1695383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2018
• 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: CANAL FILLING STEM 12X 100MM- KSP11100E.; SIZE 3, RESURFACING AXIAL PIN- 25002113E.; SIZE 3, RESURFACING FEMUR - RF-R003E-01M.; TIBIAL HINGE WITH ROTATIONAL STOP- THSMWRS01M.
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male