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

Model Number	10-10-0004
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: patient bone quality may have contributed to due to revision surgery and hence loose stem.Exact cause is unknown.No further complaint from patient or surgeon reported.
Event or Problem Description
Surgeon performed a revision surgery due to loose stem.

• Brand Name: NEXTSTEP ARTHROPEDIX
• Common Device Name: INSITU HIP SYSTEM
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• MDR Report Key: 7144032
• Report Number: 3002498892-2017-00008
• Device Sequence Number: 1238647
• Product Code: LPH
• UDI-Device Identifier: 00816127022111
• UDI-Public: 00816127022111
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Expiration Date: 10/01/2018
• Device Model Number: 10-10-0004
• Device Catalogue Number: 10-10-0004
• Device Lot Number: PC006
• 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: 10/10/2017
• 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