MAUDE Adverse Event Report: THEKEN COMPANIES NEXTSTEP ARTHROPEDIX; INSITU HIP SYSTEM

Model Number	10-40-3654
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact cause of infection was unknown.There can be multiple potential causes suring surgery that may contribute to infection.Only femoral head and acetabular liner was replaced.Size 36 x 54/56 neutral liner.Size 36 + 0mm cocr head.
Event or Problem Description
Surgeon performed a revision surgery.He left the well fixed stem and cup and replaced the liner and head.Revision surgery was performed due to infection problem.

• Brand Name: NEXTSTEP ARTHROPEDIX
• Common Device Name: INSITU HIP SYSTEM
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• MDR Report Key: 7144328
• Report Number: 3002498892-2017-00009
• Device Sequence Number: 1132665
• Product Code: LPH
• UDI-Device Identifier: 00816127022753
• UDI-Public: 00816127022753
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

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: No Information
• Device Model Number: 10-40-3654
• Device Catalogue Number: 10-40-3654
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 12/22/2017
• 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: 55 YR