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

Model Number	10-40-4054
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Dislocation after tha is a known risk and risk that is specified in the instructions for use.Dislocation can be caused by numerous events, including, but not limited to trauma, malpositioning of component, or hyperlaxity of the joint.Common treatment for dislocation is a liner and or cup that restricts range of motion.
Event or Problem Description
It was reported by the distributor that a dislocation occured in a patient.The patient went to the doctor after the dislocation.A neutral liner and ceramic femoral head were replaced.

• Brand Name: INSITU TOTAL HIP SYSTEM
• Common Device Name: NEUTRAL LINER
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron 44306
• Manufacturer Contact: jenna amawi ; 1800 triplett blvd; akron, OH 44306 ; 3307337600
• MDR Report Key: 22294065
• Report Number: 3002498892-2025-00004
• Device Sequence Number: 8310362
• Product Code: LPH
• UDI-Device Identifier: 00816127022784
• UDI-Public: 00816127022784
• Combination Product (Y/N): N
• PMA/510(K) Number: K161184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: Health Professional
• Device Model Number: 10-40-4054
• Device Lot Number: 3857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 40 MM, +4 MM CERAMIC FEMORAL HEAD; SIZE 54/56 X 40 MM NEUTRAL ACETABULAR LINER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female