MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; SEGMENTAL STEM, CANAL-FILLING 12X120MM, STRAIGHT SPLINED FULL PLASMA 28MM COLLAR

Model Number	FS-12120-03M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for investigation.The investigation is in process.When the investigation is complete, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to a periprosthetic fracture below the patient's segmental stem.The patient underwent their original surgery on (b)(6) 2020 where the following implants were placed: eleos canal-filling segmental stem (12x120mm), eleos proximal femur (95mm), eleos male-female midsection (60mm), eleos femoral head (32mm, +0mm taper), and microport guardian bipolar shell (46mm).During the revision surgery, the eleos segmental stem was explanted and an eleos distal femoral system was placed.No additional information regarding the event has been provided.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to a periprosthetic fracture below the patient's segmental stem.The patient underwent their original surgery on (b)(6) 2020 where the following implants were placed: eleos canal-filling segmental stem (12x120mm), eleos proximal femur (95mm), eleos male-female midsection (60mm), eleos femoral head (32mm, +0mm taper), and microport guardian bipolar shell (46mm).During the revision surgery, the eleos segmental stem was explanted and an eleos distal femoral system was placed.No additional information regarding the 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 periprosthetic fracture could not be determined.The device history records and sterilization batch records were reviewed and no issues during manufacturing or sterilization were identified that could 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.

• Brand Name: ELEOS
• Common Device Name: SEGMENTAL STEM, CANAL-FILLING 12X120MM, STRAIGHT SPLINED FULL PLASMA 28MM COLLAR
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 12324960
• Report Number: 3013450937-2021-00165
• Device Sequence Number: 19534932
• Product Code: JDI
• UDI-Device Identifier: B278FS1212003M0
• UDI-Public: +B278FS1212003M0
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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): 10/12/2021

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: 01/18/2024
• Device Model Number: FS-12120-03M
• Device Catalogue Number: FS-12120-03M
• Device Lot Number: 81692
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P/N 25001060E, ELEOS MALE-FEMALE MIDSECTION (60MM); P/N 26010008E, ELEOS FEMORAL HEAD, 32MM; P/N GLBP3246, GLADIATOR BIPOLAR SHELL, 46MM; P/N PF-2000L-02M, ELEOS PROXIMAL FEMUR; P/N 25001060E, ELEOS MALE-FEMALE MIDSECTION (60MM); P/N 26010008E, ELEOS FEMORAL HEAD, 32MM; P/N GLBP3246, GLADIATOR BIPOLAR SHELL, 46MM; P/N PF-2000L-02M, ELEOS PROXIMAL FEMUR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR