MAUDE Adverse Event Report: THEKEN COMPANIES INSITU HIP SYSTEM; CERAMIC FEMORAL HEAD

Model Number	10-40-3650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The head, liner, and stem were removed to address the patient's pain.Pain can be caused by multiple factors, but not limited to surgical technique, implant positioning, and patient-specific factors (e.G.Bone quality).A competitor's head and stem were used during the revision.A nextstep hooded liner was also used.
Event or Problem Description
It was reported that the patient was experiencing femoral pain and the femur had to be revised.

• Brand Name: INSITU HIP SYSTEM
• Common Device Name: CERAMIC FEMORAL HEAD
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron 44306
• Manufacturer Contact: jenna amawi ; 1800 triplett blvd; akron, OH 44306 ; 3307337600
• MDR Report Key: 22470828
• Report Number: 3002498892-2025-00007
• Device Sequence Number: 4234559
• Product Code: LPH
• UDI-Device Identifier: 00816127022739
• UDI-Public: 00816127022739
• Combination Product (Y/N): N
• PMA/510(K) Number: K161184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/08/2025

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: 10-40-3650
• Device Lot Number: 3179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2023
• 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: 36MM, +0MM CERAMIC HEAD; SIZE 2 STANDARD STEM; SIZE 50 X 36MM NEUTRAL LINER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female