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

Model Number	10-21-3201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dhr was reviewed.The devices meet dimensional specifications.The ncm log was reviewed and no ncms have been observed for these lots.There are no other complaints reported for the subject lot numbers.The cited reason for revision was stem loosening/subsidence.The patient experienced a periprosthetic femoral fracture at the primary surgery and cerclage cable used for reduction.Post-operative radiographs indicate the stem was properly aligned.The revising surgeon indicated that the femoral stem may have been undersized.The femoral stem, femoral head, and acetabular were revised, while the acetabular cups was left in-situ.Stem subsidence can be caused by multiple factors, including, but not limited to patient factors (e.G.Bone quality, comorbidities, patient activity) and surgical technique (e.G.Implant selection and alignment).The revision cannot be attributed to device malfunction based on the provided information.
Event or Problem Description
This event is also described in 3002498892-2026-00001 and 3002498892-2026-00003.It was reported that the femoral stem loosened/subsided.The femoral stem, femoral head, and acetabular liner were revised.

• Brand Name: INSITU TOTAL HIP SYSTEM
• Common Device Name: CERAMIC FEMORAL HEAD
• 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: 24676746
• Report Number: 3002498892-2026-00002
• Device Sequence Number: 15988739
• Product Code: LPH
• UDI-Device Identifier: 00816127022456
• UDI-Public: 00816127022456
• Combination Product (Y/N): N
• PMA/510(K) Number: K161184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• 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): 03/23/2026

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 Expiration Date: 10/01/2025
• Device Model Number: 10-21-3201
• Device Lot Number: 7011501285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2020
• 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: 10-10-0003; 10-21-3201; 10-41-3248
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female