MAUDE Adverse Event Report: Theken Companies TheRay Collared and Collarless Hip System; Femoral Stem

Model Number	12-10-0006
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon had difficulty seating the acetabular liner.A second acetabular liner was implanted without issue.
Additional Manufacturer Narrative
Device not returned.Dhr was reviewed for the subject lot and all specifications were met.No other complaints have been reported for this lot.An aceabular liner of the same lot was ultimately implanted.The cause for difficulty to seat an acetabular liner is potentially multifactorial, including soft-tissue impingement, component alignment prior to attempted seating, and surgical technique.The same event described in 3002498892-2026-00004, 3002498892-2026-00005, and 3002498892-2026-00007.

• Brand Name: TheRay Collared and Collarless Hip System
• Common Device Name: Femoral Stem
• Manufacturer (Section D): Theken Companies; 1800 triplett blvd; akron OH 44306
• Manufacturer Contact: garrett spurgeon ; 1800 triplett blvd; akron, OH 44306 ; +1(330)733-7600
• MDR Report Key: 50268300
• Report Number: 3002498892-2026-00006
• Device Sequence Number: 16020068
• Product Code: MEH
• UDI-Device Identifier: 00816127025310
• UDI-Public: 00816127025310
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Type of Report: Initial
• Report Date (Section B): 08/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12-10-0006
• Device Lot Number: 4018-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 10-21-3603; 10-33-0054; 10-40-3654; 12-10-0006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male