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

Model Number	316-0016
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2021 due to failure in the repair of the rotator cuff.The patient was initially implanted with humeris anatomical which was then revised to reverse configuration.A humeris stem cementless (16), double taper, 3-4 pegs glenoid and cocr head (50x20) were explanted.A glenoid baseplate (24), centered glenosphere (40/10) and post extension cementless (6) were implanted.
Event or Problem Description
The patient was revised on (b)(6) 2021 due to failure in the repair of the rotator cuff.The patient was initially implanted with humeris anatomical which was then revised to reverse configuration.A double taper, 3-4 pegs glenoid and cocr head (50x20) were explanted.A glenoid baseplate (24), centered glenosphere (40/10), post extension cementless (6), humeral cup (40/3), 2 standard screws (25 mm and 35 mm each) and 2 locking screws ( 20 mm and 25 mm each) were implanted.

• Brand Name: HUMERIS SHOULDER
• Common Device Name: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 13122151
• Report Number: 3014128390-2021-00073
• Device Sequence Number: 4666818
• Product Code: HSD
• UDI-Device Identifier: 03701037303689
• UDI-Public: 03701037303689
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022
• Report Date (Section F): 01/06/2022

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 Expiration Date: 10/01/2024
• Device Model Number: 316-0016
• Device Catalogue Number: 106-5000
• Device Lot Number: M1826
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 01/06/2022
• 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: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/06/2022