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

Lot Number 1960462

Device Problems Fitting Problem (2183); Insufficient Information (3190)

Patient Problems Joint Laxity (4526); Insufficient Information (4580)

Event Date 12/12/2023

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: 3013450937-2023-00333.3013450937-2023-00332.

Event Description

Dr.(b)(6) requested onkos custom prox tibia with interlocking screw holes.Also, onkos off the shelf dfr system.On (b)(6) 2023 patient underwent a polyswap.

Event Description

It was reported by (b)(6), an onkos sales representative, that a 78-year-old male patient underwent a revision surgery on (b)(6) 2023, to increase the thickness of the implanted poly spacer from 16mm to 20mm.The original poly spacer thickness was reportedly undersized due to an incorrect implant selection, contributing to laxity of the knee joint.

Manufacturer Narrative

It was reported by (b)(6), an onkos sales representative, that a 78-year-old male patient underwent a revision surgery on (b)(6) 2023, to increase the thickness of the implanted poly spacer from 16mm to 20mm.The original poly spacer thickness was reportedly undersized due to an incorrect implant selection, contributing to laxity of the knee joint.All inspection and manufacturing data was reviewed for the revised eleos implants; all reviewed information was 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 potentially contribute to adverse effects.The root cause of this complaint was not determined.The following mdrs are related to this adverse event: 3013450937-2023-00332.3013450937-2023-00333.3013450937-2023-00334.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Type of Device: ELEOS DISTAL FEMUR AXIAL PIN
• 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: 18415245
• MDR Text Key: 331580211
• Report Number: 3013450937-2023-00334
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 1960462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• 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: DISTAL FEMUR AXIAL PIN, 25002111E.; ELEOS TIBIAL POLY SPACER- 25001216E.; TIBIAL HINGE W/ROTATIONAL STOP- THSMWRS01M.
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male