MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; ELESO STEM EXTENSION, CANAL FILLING, 18MM X 140MM, STRAIGHT, SPLINED, SLOTTED

Model Number	KSP17140E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the component met specification.There was no indication that the manufacturing of the components contributed to this complaint.It is unknown if the patient's medical history was a contributing factor to the failure.It is unknown if the patient sustained a trauma prior to the failure.
Event or Problem Description
The patient underwent a revision surgery due to dissociation of the resurfacing femur component and the stem extension component that were implanted in their left leg by dr.(b)(6) at (b)(6) on (b)(6) 2020.The resurfacing femur component was explanted and replaced.The stem extension component was left in place.
Event or Problem Description
The patient underwent a revision surgery due to dissociation of the resurfacing femur component and the stem extension component that were implanted in their left leg by dr.(b)(6) at the (b)(6) on (b)(6) 2020.The resurfacing femur component was explanted and replaced.The stem extension component was left in place.
Additional Manufacturer Narrative
The previous submission incorrectly reported that the patient had undergone multiple revisions.It was determined on (b)(6) 2020 that these revisions were accidentally included in the report.The patient associated with this report underwent their primary eleos surgery on (b)(6) 2020.This report was completed due to a revision surgery on (b)(6) 2020.This was the first revision surgery on the patient since their primary surgery.

• Brand Name: ELEOS
• Common Device Name: ELESO STEM EXTENSION, CANAL FILLING, 18MM X 140MM, STRAIGHT, SPLINED, SLOTTED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10483147
• Report Number: 3013450937-2020-00120
• Device Sequence Number: 11785308
• Product Code: KRO
• UDI-Device Identifier: B278KSP17140E0
• UDI-Public: B278KSP17140E0
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• 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,Followup
• Report Date (Section B): 09/02/2020

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 Expiration Date: 05/22/2025
• Device Model Number: KSP17140E
• Device Catalogue Number: KSP17140E
• Device Lot Number: 1710335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/07/2020
• 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: 63 YR