MAUDE Adverse Event Report: ONKOS SURGICAL ELEOS FEMORAL HEAD; PROSTHESIS, HIP

Model Number	26010002E
Medical Device Problem Codes	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The component was unable to be obtained for further analysis.Should additional information be obtained the report will be supplemented.
Event or Problem Description
Patient underwent a revision surgery due to a dislocated femoral head.
Event or Problem Description
Patient underwent a revision surgery due to a dislocated smith & nephew constrained liner and cup.To accommodate the new liner and cup the eleos femoral head was removed during the revision surgery.
Additional Manufacturer Narrative
The device history record and sterilization batch release record were reviewed and indicated that the component involved met specification.The component was unable to be obtained for further analysis.Should additional information be obtained the report will be supplemented.

• Brand Name: ELEOS FEMORAL HEAD
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ONKOS SURGICAL; 77 e halsey road; parsippany NJ 07054
• MDR Report Key: 10722125
• Report Number: 3013450937-2020-00160
• Device Sequence Number: 14315364
• Product Code: JDI
• UDI-Device Identifier: B27826010002E0
• UDI-Public: B27826010002E0
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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 Expiration Date: 03/14/2025
• Device Model Number: 26010002E
• Device Catalogue Number: 26010002E
• Device Lot Number: 1702648
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: 61 YR