MAUDE Adverse Event Report: FH INDUSTRIE ARROW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	265152
Medical Device Problem Codes	Fracture (1260); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Loosening of the sphere after 18 months of implantation.The surgeon hasn't preceded to the revision.A revision is scheduled for (b)(6).For the moment, we have no information on device references or batches.
Event or Problem Description
Loosening of the sphere after 18 months of implantation.The surgeon hasn't proceeded to the revision.A revision is scheduled for (b)(6).For the moment, we have no information on device references or batches.

• Brand Name: ARROW
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: hind chouibani ; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 20835339
• Report Number: 3003898228-2024-00006
• Device Sequence Number: 4032550
• Product Code: PHX
• UDI-Device Identifier: 03661489651526
• UDI-Public: 03661489651526
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K202024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/21/2025
• Device Model Number: 265152
• Device Lot Number: L02288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 06/11/2025
• 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