MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM - CANAL FILLING, 20MM X 152MM, BOWED, SLOTTED, SPLINED

Model Number	2500BP20E
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the loosening was unable to be determined.The surgeon believed that the collar of the implant was too small for the cortical rim of the bone.The new implant that was placed had a larger collar.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 or the sterilization of the implants or a nonconformance.
Event or Problem Description
A (b)(6) male patient underwent a revision surgery performed by dr.(b)(6) on (b)(6) 2020 due to loosening and migration up into the femur of a segmental stem.The sales representative stated that the surgeon found that the collar of the segmental stem had slipped past the cortical rim of the bone.This led to a two-millimeter shortening of the limb.The surgeon explanted the components, removed length from the femur, and implanted new implants.The segmental stem that was explanted was a canal filling, 20mm x 152mm bowed stem.This was replaced with a cemented, 17mm x 200mm bowed stem.The 12mm tibial poly spacer was removed and replaced with a 10mm tibial poly spacer.A distal femur component, distal femur axial pin, 50mm male-female midsection, and tibial hinge component were all explanted and replaced with identical components.

• Brand Name: ELEOS
• Common Device Name: SEGMENTAL STEM - CANAL FILLING, 20MM X 152MM, BOWED, SLOTTED, SPLINED
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10823005
• Report Number: 3013450937-2020-00171
• Device Sequence Number: 11638255
• Product Code: KRO
• UDI-Device Identifier: B2782500BP20E0
• UDI-Public: B2782500BP20E0
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/11/2020

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: 03/26/2026
• Device Model Number: 2500BP20E
• Device Catalogue Number: 2500BP20E
• Device Lot Number: 1745645
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2020
• 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: 78 YR