MAUDE Adverse Event Report: TRIMED FUSION CUP, 10 HOLE, 18MM

Model Number	FC10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep reported on 18may2023 that a fc10 was removed from a patient due to discomfort, the fusion cup was originally implanted on (b)(6) 2023.It was reported that the surgeon believes the fusion cup may have taken longer to fuse due to comorbidities and poor bone quality.Upon removal it was discovered that the plate is cracked in 2 locations, however the surgeon stated the wrist successfully fused and appears to move as one unit as is the intended outcome of the procedure.The implant was successfully removed from the patient on (b)(6) 2023 and no hardware was left in the patient.
Event or Problem Description
The surgeon state that the position of the plate was not ideal that could have caused the delayed union which would have lead to fatigue of the plate.The surgeon stated that it was believed that the position of the plate was the primary problem of the patient discomfort, rather than material failure.

• Brand Name: FUSION CUP, 10 HOLE, 18MM
• Common Device Name: FUSION CUP, 10 HOLE, 18MM
• Manufacturer (Section D): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355
• MDR Report Key: 17131897
• Report Number: 2031009-2023-00004
• Device Sequence Number: 17764172
• Product Code: HRS
• UDI-Device Identifier: 00842188100734
• UDI-Public: 00842188100734
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K050681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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 Model Number: FC10
• Device Catalogue Number: FC10
• Device Lot Number: 000016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 06/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown