MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM; ELEOS SEGMENTAL STEM, CANAL FILLING, 17MM X 152MM, BOWED

Model Number	FB-17152-03M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/20/2020
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.The patient was reported to have falled from an unknown height prior to the failure of the device and it is likely that this even contributed to the failure.
Event or Problem Description
The patient underwent a revision surgery on (b)(6) 2020 due to a fractured femoral segmental stem which occured when the patient fell.This caused the stem to migrate out of position.The surgoen replaced the stem extension and added a new segment to replace bone that was removed due to a deformity in the femur.
Event or Problem Description
The patient underwent a revision surgery on (b)(6) 2020 due to a fractured femoral guardian segmental stem which occured when the patient fell.This caused the stem to migrate out of position.The surgeon replaced the stem extension with an eleos stem extension.The surgeon found a deformity to the femur that made it difficult to place the implant.Post-operative x-rays were taken and the surgeon decided to bring the patient back to remove the damaged bone.On (b)(6) 2020, the surgeon resected the damaged part of the femur and added a midsection implant to replace the length.He also replaced the eleos stem extension with a new eleos stem extension.However, there was no failure of the eleos stem extension.
Additional Manufacturer Narrative
The previous report is being amended due to new information from the complainant.The eleos component placed on (b)(6) 2020 was not the implant that was fractured after the patient fell.This was a guardian implant placed on (b)(6) 2018.The eleos stem extension was replaced on (b)(6) 2020 when the surgeon went into remove damaged bone that was found during the guardian revision on (b)(6) 2020.There was no failure of the eleos component but it was replaced due to being explanted for the surgeon to resect more femoral bone.A review of the manufacturing dhr did not find any issues with manufacturing that could have contributed to this complaint.

• Brand Name: ELEOS SEGMENTAL STEM
• Common Device Name: ELEOS SEGMENTAL STEM, CANAL FILLING, 17MM X 152MM, BOWED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany, nj
• MDR Report Key: 10409715
• Report Number: 3013450937-2020-00117
• Device Sequence Number: 16958203
• Product Code: KRO
• UDI-Device Identifier: B278FB1715203M0
• UDI-Public: B278FB1715203M0
• Combination Product (Y/N): N
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2024
• Device Model Number: FB-17152-03M
• Device Catalogue Number: FB-17152-03M
• Device Lot Number: 82297
• 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: 08/14/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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: 75 YR