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

Model Number	10-11-0006
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: the preoperative x ray showed that the femoral stem appeared to be rotated in varus and sitting proud to where the stem should be seated.It is har to tell because of the proudness and rotation, but it also may be too small.Review of photos os explanted stem, appears to have extensive collagen matrix with little to no bone on growth.This is a sign of a loose stem at initial implantation that allowed for micromotion.No issue with product performance.
Event or Problem Description
Patient presented with thigh pain consistently after primary surgery.Was followed and determined by surgeon that the stem was loose upon implantation.Stem was removed, confirmed as loose and replaced with longer stem on (b)(6) 2017.

• Brand Name: NEXTSTEP ARTHROPEDIX
• Common Device Name: INSITU HIP SYSTEM
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• MDR Report Key: 7144552
• Report Number: 3002498892-2017-00011
• Device Sequence Number: 927139
• Product Code: LPH
• UDI-Device Identifier: 00816127022135
• UDI-Public: 00816127022135
• 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 Expiration Date: 10/01/2018
• Device Model Number: 10-11-0006
• Device Catalogue Number: 10-11-0006
• Device Lot Number: PC020
• 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: 11/06/2017
• 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: 76 YR