MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; STEM, CANAL-FILLING, 11X152MM, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 28MM COLLAR

Model Number	FB-11152-03M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.Multiple mdrs were submitted for this event: #3013450937-2021-00247, #3013450937-2021-00248, #3013450937-2021-00249, #3013450937-2021-00250, #3013450937-2021-00251, #3013450937-2021-00252, #3013450937-2021-00253.
Event or Problem Description
It was reported that the patient developed an alleged infection and underwent a revision surgery on (b)(6) 2021.The following eleos implants were revised: male-female midsection (40mm).Distal femur, tibial hinge component, distal femur axial pin, and poly spacer.The following eleos implants remain implanted from the original surgery: canal-filling segmental stem (11x152mm), tibial baseplate, and canal-filling stem extension (12x100mm).No additional information regarding this adverse event has been provided.
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.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that would have contributed to this complaint.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 3331: analysis of production records h6: type of investigation code updated to 4111: communication/interviews h6: type of investigation code updated to 4110: trend analysis h6: type of investigation code updated to 4114: device not returned h6: type of investigation code updated to 4117: device not accessible for testing h6: type of investigation code updated to 4109: historical data analysis h6: investigation findings code updated to 213: no device problem found h6: investigation conclusions code updated to 4315: cause not established h10: additional narratives/data.
Event or Problem Description
It was reported that the patient developed an alleged infection and underwent a revision surgery on (b)(6) 2021.The following eleos implants were revised: male-female midsection (40mm).Distal femur, tibial hinge component, distal femur axial pin, and poly spacer.The following eleos implants remain implanted from the original surgery: canal-filling segmental stem (11x152mm), tibial baseplate, and canal-filling stem extension (12x100mm).No additional information regarding this adverse event has been provided.

• Brand Name: ELEOS
• Common Device Name: STEM, CANAL-FILLING, 11X152MM, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 28MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• Manufacturer (Section G): PHILLIPS PRECISION INC; 7 paul kohner pl; elmwood park NJ 07407
• Manufacturer Contact: sara dailey ; 77 east halsey road; parsippany, NJ 07054
• MDR Report Key: 12751639
• Report Number: 3013450937-2021-00246
• Device Sequence Number: 17373436
• Product Code: KRO
• UDI-Device Identifier: B278FB1115203M0
• UDI-Public: +B278FB1115203M0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/03/2022

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 Expiration Date: 03/04/2024
• Device Model Number: FB-11152-03M
• Device Catalogue Number: FB-11152-03M
• Device Lot Number: 82291
• 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: 10/07/2021
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2016
• 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: P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002101E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002202E, ELEOS TIBIAL BASEPLATE; P/N KSP11100E, ELEOS STEM EXTENSION; P/N 25000009E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001208E, ELEOS TIBIAL POLY SPACER; P/N 25002101E, ELEOS TIBIAL HINGE COMPONENT; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002202E, ELEOS TIBIAL BASEPLATE; P/N KSP11100E, ELEOS STEM EXTENSION
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female