MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION

Model Number 25001040E

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

The root cause for the dissociation of the resurfacing femur and the stem extension was unable to be definitively determined.The sales representative stated that the surgeon believed that due to the patient's joint line being raised and limb being shortened caused excess mechanical stress leading to the dissociation.The patient's medical history is unknown, and it is unknown whether the patient sustained a trauma prior to the failure.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture of the implants or a nonconformance.

Event Description

The patient underwent a revision surgery (b)(6) 2020 performed by dr.(b)(6) due to dissociation of the distal femur component and a male-female midsection that connected to the segmental stem.The surgeon believed that raising the joint line and shortening the limb caused increased mechanical forces on the components which led to the dissociation.The surgeon lowered the joint line and increased the limb length back to normal.The patient's proximal tibia component, distal femur component, and tibial hinge component were explanted and revised on (b)(6) 2020.The patient's 10mm tibial poly spacer was explanted and replaced with an 8mm tibial poly spacer on (b)(6) 2020.A 140mm male-female midsection, a 70mm male-female midsection, and a 50 male-female midsection were placed on (b)(6) 2020 to replace a 90mm male-female midsection, two 40mm male-female midsections, and a 100mm male-female midsection.

• Brand Name: ELEOS
• Type of Device: MALE-FEMALE MIDSECTION
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): MICROPORT ORTHOPEDICS; 5677 airline road; arlington TN 38002
• Manufacturer Contact: jonathan zachok ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 10634920
• MDR Text Key: 233174305
• Report Number: 3013450937-2020-00143
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: B27825001040E0
• UDI-Public: B27825001040E0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25001040E
• Device Catalogue Number: 25001040E
• Device Lot Number: 1841365
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR