MAUDE Adverse Event Report: THEKEN COMPANIES THERAY; COLLARED FEMORAL STEM

Model Number	12-10-0002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/17/2025
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 implant was revised due to trauma.The information provided does not suggest that the nextstep arthropedix hip system malfunctioned.Per the nextstep arthorpedix instructions for use - "all prosthetic replacements have the potential for adverse effects, including but not limited to, infection, loosening, fracture, breakage, bending of the components, component disassembly, or positional changes of the components.".
Event or Problem Description
It was reported that a patient fell and sustained a fracture (traumatic periprosthetic femoral fracture).The nextstep arthropedix femoral stem was revised using a competitor stem and head.The nextstep arthropedix acetabular cup was left in-situ and the neutral liner was replaced with a nextstep arthropedix hooded liner.

• Brand Name: THERAY
• Common Device Name: COLLARED FEMORAL STEM
• Manufacturer (Section D): THEKEN COMPANIES; 1800 triplett blvd; akron OH 44306
• Manufacturer Contact: jenna amawi ; 1800 trplett blvd; akron, OH 44306 ; 3307337600
• MDR Report Key: 23329367
• Report Number: 3002498892-2025-00025
• Device Sequence Number: 9910027
• Product Code: LPH
• UDI-Device Identifier: 00816127025273
• UDI-Public: 00816127025273
• Combination Product (Y/N): N
• PMA/510(K) Number: K241875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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: 12-10-0002
• Device Lot Number: 4014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: CERAMIC FEMORAL HEAD.; COLLARED FEMORAL STEM.; HOLED ACETABULAR CUP.; NEUTRAL LINER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female