MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM CEMENTED 13MM X 120MM STRAIGHT FLUTED 28MM COLLAR

Model Number	CS-13120-03M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	03/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is in progress.When it is complete a supplemental mdr will be submitted accordingly.Mulitple mdrs were submitted for this adverse event: 3013450937-2022-00135, 3013450937-2022-00136, 3013450937-2022-00137, 3013450937-2022-00138, 3013450937-2022-00139 and 3013450937-2022-00141.
Event or Problem Description
On (b)(6) 2022 the patient received a superficial wound debridement to treat a superficial suture and sub-q abscess that developed after receiving distal femoral replacement surgery.
Event or Problem Description
On (b)(6) 2022 the patient received a superficial wound debridement to treat a superficial suture and sub-q abscess that developed after receiving distal femoral replacement surgery.
Additional Manufacturer Narrative
This report is being submitted to include additional information.The investigation is complete.The device was not returned for evaluation.The root cause of the alleged infection could not be determined.If any additional information is obtained, a supplemental mdr will be filed accordingly.The following sections were updated: b4: date of this report added g3: date received by manufacturer added g6: type of report added h2: follow-up type added h3: device evaluated by manufacturer updated to no h6: type of investigation code updated to 4110: trend analysis h6: type of investigation code updated to 4117: device not accessible for testing h6: investigation findings code updated to 3221: no findings available h6: investigation conclusions code updated to 4315: cause not established h10: additional narratives/data.

• Brand Name: ELEOS
• Common Device Name: SEGMENTAL STEM CEMENTED 13MM X 120MM STRAIGHT FLUTED 28MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC.; 7 paul kohner place; elmwood park NJ 07407
• Manufacturer Contact: danielle pierce ; 77 east halsey road; parsippany 07054 ; 8447672766
• MDR Report Key: 14138164
• Report Number: 3013450937-2022-00140
• Device Sequence Number: 4237727
• Product Code: KRO
• UDI-Device Identifier: B278CS1312003M0
• UDI-Public: B278CS1312003M0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2022

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: CS-13120-03M
• Device Catalogue Number: CS-13120-03M
• Device Lot Number: 91399-007
• 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: 03/19/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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: 25000009E ELEOS DISTAL FEMUR RIGHT SEGMENTAL; 25001210E ELEOS TIBIAL POLY SPACER 10MM; 25002111E ELEOS DISTAL FEMUR AXIAL PIN; KSC01465E ELEOS STEM EXTENSION CEMENTED 14MMX65MM; TB-2202E-01M ELEOS TIBIAL BASEPLATE SIZE 2; THSMWRS01M ELEOS TIBIAL HINGE W/ ROTATIONAL STOP
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female