MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS HUMERIS; REVERSED SHOULDER PROTHESIS

Catalog Number 313-0703

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 03/05/2024

Event Type  Injury  

Event Description

The patient was revised due to dismantling on (b)(6) 2024.The implantation date was on (b)(6) 2024.A cup and a glenosphere were explanted.A cup and a glenosphere were implanted.

Manufacturer Narrative

The event took place outside the united states (in france) and was associated with a product that is also cleared for the market in the united states.

• Brand Name: HUMERIS
• Type of Device: REVERSED SHOULDER PROTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SHOULDER SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: emeric obin ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 18920739
• MDR Text Key: 337859030
• Report Number: 3009532798-2024-00023
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037301357
• UDI-Public: 03701037301357
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 313-0703
• Device Lot Number: U1198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization