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

Catalog Number 106-4800

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2021 due to rotator cuff failure, approximately 9 months following primary surgery.Surgeon converted anatomic configuration to a reverse, explanting all components except the stem (3-4 peg glenoid size s, size 48 +5mm centered spacer, and 48x19 offset cocr head) and then implanting reverse components (135/145 36/+3 standard humeral cup, 36mm centered glenosphere with screw, 24mm glenoid baseplate, +6mm post extension, and 3 screws).

• 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: 12623954
• MDR Text Key: 276414327
• Report Number: 3014128390-2021-00051
• 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

• Date FDA Received: 10/13/2021
• 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: N3232
• 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: 09/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• 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: 61 YR