MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS SEGMENTAL STEM CEMENTED; PROSTHESIS, HIP

Model Number	25004013E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is for one of three devices involved in the event, please refer to report 3013450937-2019-00016 and 3013450937-2019-00017.The sales representative notified the manufacture that the patient retained a foreign body and during the revision surgery a gauze sponge was found in the joint and likely led to the patient's infection and inflammatory reaction.The device history records, sterilization batch release records, and patient information found that the design, manufacturing, and/or sterilization did not lead to this complaint.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient had an infection and inflammatory reaction in their hip, which required surgical intervention to remove all implants.

• Brand Name: ELEOS SEGMENTAL STEM CEMENTED
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ONKOS SURGICAL; 77 east halsey road; parsippany NJ 07054
• MDR Report Key: 8608619
• Report Number: 3013450937-2019-00015
• Device Sequence Number: 13976204
• Product Code: JDI
• UDI-Device Identifier: B27825004013E0
• UDI-Public: B27825004013E0
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 07/17/2026
• Device Model Number: 25004013E
• Device Catalogue Number: 25004013E
• Device Lot Number: 1751811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/14/2019
• 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: 78 YR