MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	105-3613
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2021 after primary surgery on (b)(6) 2021 for dislocation due to proximal humeral fracture.The surgeon explanted an eccentric glenosphere (36), humeral spacer (9) and humeral cup (36/9).The surgeon implanted 2 cortical screws (1 of 28mm and 26 mm each), eccentric glenosphere (40), humeral spacer (9) and humeral cup (36/6).

• Brand Name: HUMELOCK REVERSED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 13172503
• Report Number: 3014128390-2021-00078
• Device Sequence Number: 4562226
• Product Code: PHX
• UDI-Device Identifier: 03701037300275
• UDI-Public: 03701037300275
• 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
• Report Date (Section B): 01/05/2022
• Report Date (Section F): 01/05/2022

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
• Device Expiration Date: 11/01/2022
• Device Model Number: 105-3613
• Device Catalogue Number: 105-3613
• Device Lot Number: L1846
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2022
• 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: 82 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/05/2022