MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; CANAL-FILLING BOWED SEGMENTAL STEM 17X152MM

Model Number	FB-17152-03M
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing pain.Radiographically, it was found that the patient's 17x152mm canal-filling bowed segmental stem had loosened.The patient underwent a revision surgery on (b)(6) 2022 where the surgeon revised the patient's 17x152mm canal-filling bowed segmental stem to a 19x152mm canal-filling bowed segmental stem.The surgeon also revised the distal femur, 2 male-female midsections, tibial hinge component, and distal femur axial pin.No additional information regarding this adverse event has been provided.
Additional Manufacturer Narrative
The investigation is in process.When the investigation is complete, a supplemental mdr will be submitted accordingly.
Event or Problem Description
It was reported that the patient was experiencing pain.Radiographically, it was found that the patient's 17x152mm canal-filling bowed segmental stem had loosened.The patient underwent a revision surgery on (b)(6) 2022 where the surgeon revised the patient's 17x152mm canal-filling bowed segmental stem to a 19x152mm canal-filling bowed segmental stem.The surgeon also revised the distal femur, 2 male-female midsections, tibial hinge component, and distal femur axial pin.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 segmental stem loosening 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: 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.

• Brand Name: ELEOS
• Common Device Name: CANAL-FILLING BOWED SEGMENTAL STEM 17X152MM
• 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: 14880608
• Report Number: 3013450937-2022-00196
• Device Sequence Number: 6206811
• Product Code: KRO
• UDI-Device Identifier: B278FB1715203M0
• UDI-Public: B278FB1715203M0
• 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
• Device Explanted 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): 08/26/2022

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: FB-17152-03M
• Device Catalogue Number: FB-17152-03M
• Device Lot Number: 86829
• 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: 06/01/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/26/2022
• 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: P/N 25000007E, ELEOS DISTAL FEMUR; P/N 25001040E, ELEOS MALE-FEMALE MIDSECTION; P/N 25001060E, ELEOS MALE-FEMALE MIDSECTION; P/N 25002111E, ELEOS DISTAL FEMUR AXIAL PIN; P/N 25002204E, ELEOS TIBIAL BASEPLATE; P/N KPONTP38E, ELEOS RESURFACING PATELLA; P/N KSP15100E, ELEOS STEM EXTENSION; P/N THSMWRS01M, ELEOS TIBIAL HINGE COMPONENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female