MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; FEMORAL HEAD, SUPER FINISH, 36MM, +0MM TAPER

Model Number	26000026E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Unspecified Infection (1930)
Date of Event	07/18/2021
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.Multiple mdrs were reported for this event: #3013450937-2021-00159, #3013450937-2021-00160, #3013450937-2021-00161, #3013450937-2021-00162.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The patient had fallen and it caused an open sore on their left hip.The patient laid with an open wound for approximately two weeks.During the revision surgery, the surgeon performed heavy incision and drainage and performed a bipolar exchange for infection control.The following implants remain implanted from the original surgery on (b)(6) 2020: eleos proximal femur (98mm), eleos male-female midsection (110mm), eleos male-female midsection (70mm), and eleos cemented stem (15x120mm).The following implants were revised during the revision surgery: eleos femoral head (36mm, +0mm taper) and a microport gladiator bipolar shell (56mm).No additional information regarding this event has been obtained.
Event or Problem Description
It was reported that the patient underwent a revision surgery on (b)(6) 2021 due to an alleged infection.The patient had fallen and it caused an open sore on their left hip.The patient laid with an open wound for approximately two weeks.During the revision surgery, the surgeon performed heavy incision and drainage and performed a bipolar exchange for infection control.The following implants remain implanted from the original surgery on (b)(6) 2020: eleos proximal femur (98mm), eleos male-female midsection (110mm), eleos male-female midsection (70mm), and eleos cemented stem (15x120mm).The following implants were revised during the revision surgery: eleos femoral head (36mm, +0mm taper) and a microport gladiator bipolar shell (56mm).No additional information regarding this event has been obtained.
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 patient 's fall and 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 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: FEMORAL HEAD, SUPER FINISH, 36MM, +0MM TAPER
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey rd; parsippany NJ 07054
• MDR Report Key: 12273487
• Report Number: 3013450937-2021-00163
• Device Sequence Number: 14231272
• Product Code: JDI
• UDI-Device Identifier: B27826000026E0
• UDI-Public: B27826000026E0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/04/2021

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: 08/13/2026
• Device Model Number: 26000026E
• Device Catalogue Number: 26000026E
• Device Lot Number: 1768551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 10/04/2021
• 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 25001070E, ELEOS MALE-FEMALE MIDSECTION (70MM); P/N 25001110E, ELEOS MALE-FEMALE MIDSECTION(110MM); P/N CS-15120-03M, ELEOS CEMENTED STEM; P/N GLBP3656, MICROPORT GLADIATOR BIPOLAR SHELL; P/N PF-2000L-02M, ELEOS BIOGRIP PROXIMAL FEMUR; P/N 25001070E, ELEOS MALE-FEMALE MIDSECTION (70MM); P/N 25001110E, ELEOS MALE-FEMALE MIDSECTION(110MM); P/N CS-15120-03M, ELEOS CEMENTED STEM; P/N GLBP3656, MICROPORT GLADIATOR BIPOLAR SHELL; P/N PF-2000L-02M, ELEOS BIOGRIP PROXIMAL FEMUR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 24 YR