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

Model Number	10110008
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No exact cause of the femur fracture is known.There has been no non-conformances related to this product or lot.Product malfunction is ruled out.Surgical techniques, patient care after surgery, implant sizing, etc.There are multiple probable cause for this event.Since this is a reportable adverse event, mdr is filed.No issue with product or processes.
Event or Problem Description
Primary surgery was performed on (b)(6) 2018.Revision conducted 10 days after primary.Surgeon took out the stem and took off the head, but left the cup and liner.Femur had fractured medially, and stem had subsided.

• Brand Name: INSITU HIP SYSTEM
• Common Device Name: INSITU HIP REPLACEMENT SYSTEM
• Manufacturer (Section D): THEKEN COMPANIES, LLC; 1800 triplett blvd; akron OH 44306
• MDR Report Key: 8053457
• Report Number: 3002498892-2018-00016
• Device Sequence Number: 1586415
• Product Code: LPH
• UDI-Device Identifier: 00816127022159
• UDI-Public: 00816127022159
• Combination Product (Y/N): N
• PMA/510(K) Number: K161184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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: 07/01/2022
• Device Model Number: 10110008
• Device Lot Number: 1088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/08/2018
• 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