MAUDE Adverse Event Report: TRIMED, INC. FUSION CUP, 10 HOLE, 18MM; FC10

Catalog Number	FC10
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep reported on 26nov2025 that a fc10 had to be removed from a patient due to a non-union.After the device was removed, it was discovered that the fc10 was cracked/broken.The device and the reps' field feedback form was mailed to trimed and received on 11dec2025 which is when the information about the return was forwarded to the quality department.Quality followed up with the rep on 11dec2025 which the rep provided additional information on 15dec2025.The rep stated that they are not sure when the device was originally implanted, he assumes the discomfort was related to the fact that this was a non-union, he does not know what was used to replace the device and he does not know what caused the non-union.Patient related information is unknown.The removal surgery was successful but there were no x-rays provided.

• Brand Name: FUSION CUP, 10 HOLE, 18MM
• Common Device Name: FC10
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 23865591
• Report Number: 2031009-2025-00028
• Device Sequence Number: 19988377
• Product Code: HRS
• UDI-Device Identifier: 00842188100734
• UDI-Public: 00842188100734
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K050681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: FC10
• Device Lot Number: AX21003
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown