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

Model Number	10-21-3601
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the distributor, the patient was a high bmi patient that had laxity over time requiring added.Length on the head.There were no other complications that happened with the implants.A 36mm, +0mm ceramic femoral head was revised with a 36mm, +10mm cocr femoral head.The primary contributing factor appears to be the patient's elevated bmi leading to soft tissue laxity.The revision surgery was unrelated to the implants.Performance.
Event or Problem Description
The distributor reported that the patient was a high bmi patient that had laxity over time requiring added length on the head.There were no other.Complications that happened with the implants.The original surgery took place in (b)(6) 2023.The revision of the ceramic head occurred on (b)(6) 2025.

• Brand Name: INSITU TOTAL 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: 22287131
• Report Number: 3002498892-2025-00002
• Device Sequence Number: 8930143
• Product Code: LPH
• UDI-Device Identifier: 00816127022494
• UDI-Public: 00816127022494
• 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): 05/20/2025

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: 10-21-3601
• Device Lot Number: 7011744494
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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 FEMORAL HEAD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female