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

Catalog Number 106-4800

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/20/2021

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2021 approximately 5 months following primary surgery.Surgeon explanted +0mm double taper and 48x19 offset cocr head, and then implanted a new +0mm double taper and 50x20 offset cocr head.

• Brand Name: HUMERIS CEMENTLESS ANATOMIC
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS SAS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12623958
• MDR Text Key: 276479352
• Report Number: 3014128390-2021-00053
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 106-4800
• Device Lot Number: P0455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2021
• Distributor Facility Aware Date: 09/20/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 10/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR