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

Catalog Number 106-4600

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of Range of Motion (2032)

Event Date 08/09/2021

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2021 due to limited range of motion approximately 2 years following primary surgery.Surgeon converted anatomic configuration to a reverse configuration, explanting all components except the humeral stem (3-4 peg glenoid size m, +0mm double taper, 46x18 offset cocr head), and then implanting components required for a reverse (24mm glenoid baseplate, 36mm centered glenosphere with screw, 135/145 36/+3 standard humeral cup, 4 screws).

• Brand Name: HUMERIS CEMENTLESS ANATOMICAL
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS SAS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12390527
• MDR Text Key: 268881264
• Report Number: 3014128390-2021-00044
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 106-4600
• Device Lot Number: M1061
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2021
• Distributor Facility Aware Date: 08/09/2021
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/11/2021
• 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: 80 YR