MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELEOS FEMORAL HEAD, 28MM

Lot Number 1762434

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Joint Dislocation (2374)

Event Date 11/02/2023

Event Type  Injury  

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.

Event Description

On (b)(6) 2023, removed failed intertroch nail and implanted proximal femur.On (b)(6) 2023, proximal femur dislocated so swapped to constrained liner.The other implants from (b)(6) 2023 remain in the patient: proximal femur, left and cemented collar.

Manufacturer Narrative

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 left hip dislocation was not related to the design, manufacture, and/or sterilization of previously implanted femoral head.

Event Description

On (b)(6) 2023, a 71-year-old male patient underwent a revision surgery due to dislocation of the left hip.During the revision surgery, the patient's acetabular liner was replaced with a constrained acetabulum liner, and the femoral head was revised.The concurrent eleos implants remaining in the patient are the left proximal femur and cemented stem.The patient had previously received an eleos proximal femur replacement on (b)(6) 2023 due to an alleged failure of an intertrochanteric nail.Eleos devices implanted at the time were: 13mmx120mm cemented stem, left proximal femur, and femoral head.

• Brand Name: ELEOS
• Type of Device: ELEOS FEMORAL HEAD, 28MM
• 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: 18243162
• MDR Text Key: 329429601
• Report Number: 3013450937-2023-00298
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 1762434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 01/31/2024
• 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: CEMENTED COLLAR 13X120MM,; FEMORAL HEAD 28MM - 26012802E.; PROXIMAL FEMUR, LEFT - PF-2000L-02M,
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male