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

Model Number	10-21-3200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product not returned.Device history record was reviewed and devices found to be within specification.Ncms were reviewed and no ncms were found for other components of the same part or lot number.Sterilization records were reviewed and found to be within specification.Devices were not expired at the point of use.There are no reported issues with other acetabular liners or femoral heads from the same lots.Per the local representative, the surgeon performed irrigation and debridement and replaced the femoral head and liner as a precautionary measure.Infection is a known risk for total hip arthroplasty, as documented in the instructions for use.The potential cause for infection is multifactorial, including, but not limited to, patient related factors (comorbidities, immunocompromise, preexisting infection, lifestyle factors, etc.), surgical factors (or environment, surgical technique, prophylaxis), post-operative factors (wound complications, care environment, delayed infection sources, etc.), or implant cleaning/sterilization issues.The root cause of the reported infection is unknown based on the available information and cannot be attributed to device performance at this time.
Event or Problem Description
It was reported that the patient had an infection.This event is also described in 3002498892-2025-00029.

• Brand Name: INSITU TOTAL HIP SYSTEM
• Common Device Name: NEUTRAL ACETABULAR LINER
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• Manufacturer Contact: garrett spurgeon ; 1800 triplett blvd; akron, OH 44306 ; 3307337600
• MDR Report Key: 23733721
• Report Number: 3002498892-2025-00030
• Device Sequence Number: 18579588
• Product Code: LPH
• UDI-Device Identifier: 00816127022715
• UDI-Public: 00816127022715
• 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): 12/05/2025

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: 10-21-3200
• Device Lot Number: 7011699260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2022
• 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: 10-21-3200.; 10-40-3246.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female