MAUDE Adverse Event Report: THEKEN COMPANIES INSITU HIP SYSTEM; TOTAL HIP REPLACEMENT SYSTEM

Model Number 10-10-0008

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

This is an adverse event per the mdr definition of reportable event.Event is not related to product malfunction.It was an accident with the patient.No such complaints related to same product and lot number.No further investigation is required on this event.

Event Description

Surgeon notified that his patient was going to have a revision hip surgery.The patient had a nextstep hip implanted on (b)(6) 2018.She went to sit on her swivel office chair with wheels and fell.There was a small fracture just beyond the tip of the stem, so surgeon opted to put a longer stem in with cables.

• Brand Name: INSITU HIP SYSTEM
• Type of Device: TOTAL HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• Manufacturer Contact: shekhar ganore ; 1800 triplett blvd; akron, OH 44306 ; 3304004797
• MDR Report Key: 7474177
• MDR Text Key: 106958088
• Report Number: 3002498892-2018-00004
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2022
• Device Model Number: 10-10-0008
• Device Catalogue Number: 10-10-0008
• Device Lot Number: 1078
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 163