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

Model Number	25001110E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The patient underwent a revision surgery (b)(6) 2020 performed by (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
• Common Device Name: MALE-FEMALE MIDSECTION
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10634924
• Report Number: 3013450937-2020-00140
• Device Sequence Number: 19623427
• Product Code: KRO
• UDI-Device Identifier: B27825001110E0
• UDI-Public: B27825001110E0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 25001110E
• Device Catalogue Number: 25001110E
• Device Lot Number: 1834409
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR