MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS LIMB SALVAGE SYSTEM; PROXIMAL TIBIA WITH BIOGRIP

Model Number	PT-20000-02M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No additional information is available at this time.Once additional information is received, this record will be updated accordingly.
Event or Problem Description
It was reported that a patient underwent revision surgery on (b)(6) 2022 due to suture tearing post-operatively.The tibial tubercle was no longer attached to the eleos proximal tibia implant, causing the patient to experience anterior knee pain.During the revision procedure, the eleos tibial polyspacer, eleos tibial hinge, eleos resurfacing femur axial pin, and eleos proximal tibia were replaced.No specific device failures related to an onkos implant were reported.However, this event will be reported as a serious injury due to revision procedure.This record captures the eleos proximal tibia.
Additional Manufacturer Narrative
It was reported that a patient underwent a revision surgery on (b)(6) 2022 due to suture tearing on the eleos proximal tibia approximately 8 months post-operatively, contributing to the detachment of the tibial tubercle.The patient experienced anterior knee pain due to this issue.The implanted proximal tibia was removed and replaced, as well as the tibial poly spacer, tibial hinge component, and axial pin.There were no alleged issues with the tibial poly spacer, tibial hinge component, or axial pin.A review of the work orders and sterilization batch release records for the products involved found no indication that the sutures tearing on the proximal tibia suture holes was a result of a manufacturing or sterilization nonconformance.The eleos complaint history record was reviewed, for the past year, which found no previous complaints for post-operative suture tears.The root cause of this event could not be determined conclusively.Upon correspondence with the field representative, it was communicated that the patient did not undergo a gastroc flap procedure, which aids the healing process by providing ample coverage over the suture area.The patient followed the recommended postoperative care and did not experience any excessive bending/loading forces.From the available information, it cannot be determined if the suture holes on the complaint proximal tibia contributed to the suture's tearing post-operatively.No intra-operative issues were reported- the sutures were able to be placed as intended during the index procedure.
Event or Problem Description
It was reported that a patient underwent revision surgery on (b)(6) 2022 due to suture tearing post-operatively.The tibial tubercle was no longer attached to the eleos proximal tibia implant, causing the patient to experience anterior knee pain.During the revision procedure, the eleos tibial polyspacer, eleos tibial hinge, eleos resurfacing femur axial pin, and eleos proximal tibia were replaced.No specific device failures related to an onkos implant were reported.However, this event will be reported as a serious injury due to revision procedure.This record captures the eleos proximal tibia.

• Brand Name: ELEOS LIMB SALVAGE SYSTEM
• Common Device Name: PROXIMAL TIBIA WITH BIOGRIP
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey rd; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: upasana basnet ; 77 e halsey rd; parsippany, NJ 07054
• MDR Report Key: 13840377
• Report Number: 3013450937-2022-00117
• Device Sequence Number: 11944846
• Product Code: KRO
• UDI-Device Identifier: B278PT2000002M0
• UDI-Public: B278PT2000002M0
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: PT-20000-02M
• Device Catalogue Number: PT-20000-02M
• Device Lot Number: 88658RR-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELEOS CANAL FILLING STEM, P/N FS-14120-03M; ELEOS CANAL FILLING STEM, P/N FS-14120-03M; ELEOS RESURFACING FEMUR AXIAL PIN, P/N 25002113E; ELEOS RESURFACING FEMUR AXIAL PIN, P/N 25002113E; ELEOS RESURFACING FEMUR, P/N 250L003E; ELEOS RESURFACING FEMUR, P/N 250L003E; ELEOS STEM EXTENSION, P/N KSP13140E; ELEOS STEM EXTENSION, P/N KSP13140E; ELEOS TIBIAL HINGE, P/N THSMWRS01M; ELEOS TIBIAL HINGE, P/N THSMWRS01M; ELEOS TIBIAL POLYSPACER, P/N 25001208E; ELEOS TIBIAL POLYSPACER, P/N 25001208E
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female