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

Model Number	10-40-3652
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Originally a standard femoral stem, neutral liner, solid acetabular cup, and 36mm, -4mm ceramic head were implanted.The stem was replaced with a lateralized stem, hooded liner, and 36mm, +0 mm ceramic head.The distributor, reported that the femoral stem was well fixed following the dislocation, but upon reduction it was determined that the joint was instable with notable laxity.The surgeon opted to increase stability of the joint but implanting a lateralized insitu femoral stem to increase stability.The surgeon replaced the femoral head since a new stem was implanted.The neutral liner was replaced with a hooded liner to provide additional articular surface area and further reduce the risk of future dislocation.Joint laxity, and subsequent dislocation, has a variety of potential causes including, but not limited to, surgical implant selection and patient factors.Dislocation is a known and documented risk for total hip replacement.
Event or Problem Description
It was reported that a patient dislocated.The distributor stated that a lateralized stem in addition to a longer ceramic head and hooded liner were used during revision for greater stability.

• Brand Name: INSITU HIP SYSTEM
• Common Device Name: NEUTRAL LINER
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• Manufacturer Contact: jenna amawi ; 1800 triplett blvd; akron, OH 44306 ; 3307337600
• MDR Report Key: 22675619
• Report Number: 3002498892-2025-00011
• Device Sequence Number: 9663558
• Product Code: LPH
• UDI-Device Identifier: 00816127022746
• UDI-Public: 00816127022746
• 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): 07/30/2025

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: 10-40-3652
• Device Lot Number: 3537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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, -4MM CERAMIC FEMORAL HEAD.; SIZE 52 X 36MM NEUTRAL LINER.; SIZE 7 STANDARD FEMORAL STEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male