MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS CEMENTLESS ANATOMICAL; SHOULDER PROSTHESIS

Model Number	DIAMETER 46 mm OFFSET
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number (b)(4).
Event or Problem Description
Patient revised on (b)(6) 2021 due to limited range of motion approximately 2 years following primary surgery.Surgeon converted anatomic configuration to a reverse configuration, explanting all components except the humeral stem (3-4 peg glenoid size m, +0mm double taper, 46x18 offset cocr head), and then implanting components required for a reverse (24mm glenoid baseplate, 36mm centered glenosphere with screw, 135/145 36/+3 standard humeral cup, 4 screws).

• Brand Name: HUMERIS CEMENTLESS ANATOMICAL
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12452023
• Report Number: 3009532798-2021-00134
• Device Sequence Number: 19134266
• Product Code: HSD
• UDI-Device Identifier: 03701037300497
• UDI-Public: 03701037300497
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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: No Information
• Device Expiration Date: 06/01/2023
• Device Model Number: DIAMETER 46 mm OFFSET
• Device Catalogue Number: 106-4600
• Device Lot Number: M1061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR