MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION

Model Number	25001060E
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the patient's hip pain was unable to be definitively determined.The patient has undergone multiple revision surgeries in a relatively short period of time.The patient was reported to not be compliant with post-operative instructions from the surgeon due to her having dementia.Due to being demented, she may have exacerbated the post-operative complications.Based on review of the device history records and sterilization batch release records, it was concluded that the failure was not associated with the manufacture or the sterilization of the implants or a nonconformance.
Event or Problem Description
A (b)(6)-year-old female patient was experiencing pain in her hip after multiple revision surgeries had been performed over the past year.This issue started on (b)(6) 2021.Scar tissue had developed in the soft tissue cavity from the previous surgeries.The surgeon, dr.(b)(6), decided that the patient's segments should be shortened to relieve the pain.A revision surgery was performed on (b)(6) 2021 where a 60mm male-female midsection was removed and replaced with a 40mm male-female midsection and a 50mm male-male midsection was removed and replaced with a 40mm male-male midsection.The primary eleos surgery, which was performed for unknown reasons, was performed on (b)(6) 2020 to place a total femur system.The patient had a proximal femur implant and a male-female midsection revised during her previous revision surgery which occurred on (b)(6) 2020.During the revision on (b)(6) 2021, a 50mm male-male midsection was replaced with a 40mm male-female midsection.A 40mm male-female midsection and a proximal femur were replaced with the same sized implants.A 60mm male-female midsection was present during the revision but was not revised.It is believed that the patient has a microport bipolar cup and femoral head implanted.

• Brand Name: ELEOS
• Common Device Name: MALE-FEMALE MIDSECTION
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 11624550
• Report Number: 3013450937-2021-00033
• Device Sequence Number: 3546500
• Product Code: KRO
• UDI-Device Identifier: B27825001060E0
• UDI-Public: B27825001060E0
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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 Model Number: 25001060E
• Device Catalogue Number: 25001060E
• Device Lot Number: 1808323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR