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

Model Number 10-11-0007

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 05/15/2017

Event Type  Injury  

Manufacturer Narrative

Cause for infection is unknown.No malfunction with the device.No other issues reported for same product lots.Probable cause may be surgery related or patient health.

Event Description

Patient developed infection 3 weeks post operation.Revision surgery required removal of implants and administered antibiotic spacer.Mdr was delayed due to administrative, technical issues with esg account and digital certificate.

• 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 ; 3307337600
• MDR Report Key: 7068031
• MDR Text Key: 93244596
• Report Number: 3002498892-2017-00002
• Device Sequence Number: 1
• Product Code: KWY
• 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: 11/29/2017

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
• Device Operator: No Information
• Device Expiration Date: 10/01/2018
• Device Model Number: 10-11-0007
• Device Catalogue Number: 10-11-0007
• Device Lot Number: PC021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2017
• 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: 70 YR