MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS; MALE-FEMALE MIDSECTION, 110MM

Model Number	25001110E
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause for the infection was unable to be determined.The patient's medical history is unknown.However, it was reported that he has had infections of surgical sites in the past and required limb salvage surgery due to infection of their primary knee arthroplasty 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 sterilization of the implants or a nonconformance during manufacturing.
Event or Problem Description
A patient underwent a revision surgery performed by dr.(b)(6) on (b)(6) 2020 at (b)(6) medical center, (b)(6), due to an infection.The patient underwent an incision and drainage procedure in an attempt to clean the infected area.A new midsection and segmental stem were placed after explanting the previously implanted components to facilitate removal of the infection.The midsection that was placed during the previous revision surgery was 110mm in length and it was replaced with a 140mm midsection.This was done for an unknown reason.
Event or Problem Description
A patient underwent a revision surgery performed by (b)(6) on (b)(6) 2020 at (b)(6) due to an infection.The patient underwent an incision and drainage procedure in an attempt to clean the infected area.A new midsection and segmental stem were placed after explanting the previously implanted components to facilitate removal of the infection.The midsection that was placed during the previous revision surgery was 110mm in length and it was replaced with a 140mm midsection.This was done for an unknown reason.
Additional Manufacturer Narrative
The name of the initial reported in section e1 was initially reported as (b)(6).The correct name of the initial reporter (b)(6).The name has been corrected.

• Brand Name: ELEOS
• Common Device Name: MALE-FEMALE MIDSECTION, 110MM
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 10520820
• Report Number: 3013450937-2020-00132
• Device Sequence Number: 3182500
• Product Code: KRO
• UDI-Device Identifier: B27825001110E0
• UDI-Public: B27825001110E0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 25001110E
• Device Catalogue Number: 25001110E
• Device Lot Number: 1807961
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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: 73 YR