MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; ELEOS CANAL FILLING STEM

Lot Number 92364-027

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682)

Event Date 09/28/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress, additional information for this event is not known at this time, if additional information is received, a supplemental report will be submitted accordingly.The following mdrs were submitted 3013450937-2023-00229, 3013450937-2023-00230, 3013450937-2023-00231, 3013450937-2023-00232, 3013450937-2023-00233, 3013450937-2023-00235, 3013450937-2023-00236, 3013450937-2023-00237.

Event Description

This patient originally received a dfr on (b)(6) 2023 and he presented with symptoms of possible infection.The doctor decided to bring the patient back for a full washout and poly exchange.This was the first washout/exchange.

Manufacturer Narrative

Ultimately, the root cause of the patient's infection was unable to be determined.Based upon the device history records, sterilization records, and interview with the sales representative the investigation concluded that the root causes of the alleged infection is not likely due to the design, manufacture, and/or sterilization of the components.The following mdrs were submitted together as part of this complaint and investigation: 3013450937-2023-00229; 3013450937-2023-00243; 3013450937-2023-00244; 3013450937-2023-00245; 3013450937-2023-00246; 3013450937-2023-00247; 3013450937-2023-00248; 3013450937-2023-00249; 3013450937-2023-00251.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: ELEOS CANAL FILLING STEM
• Manufacturer (Section D): ONKOS SURGICAL; 77 e. halsey road; parsipanny NJ 07054
• Manufacturer (Section G): ONKOS SURGICAL; 77 e. halsey road; parsipanny NJ 07054
• Manufacturer Contact: vandita patel ; 77 e. halsey road; parsipanny, NJ 07054
• MDR Report Key: 18025364
• MDR Text Key: 326797248
• Report Number: 3013450937-2023-00244
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 92364-027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• 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: 25001090E, 25001050E- MALE FEMALE MIDSECTION; 25001208E, TIBIAL 8MM POLY SPACER; CANAL FILLING STEM FS-12120-03M; DISTAL FEMUR 25000007E; DISTAL FEMUR AXIAL PIN, 25002111E; STEM EXTENSION CEMENTED KSC01465E; THSMWRS01M, HINGE W ROTATIONAL STOP; TIBIAL BASEPLATE, TB-2202E-01M
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male