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

Catalog Number 106-4800

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 06/07/2021

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2021 due to continued pain following primary surgery on (b)(6) 2020.Surgeon converted anatomic to a reverse, explanting all components except stem (3-4 peg glenoid size l, 48x19 offset cocr head, +0mm double taper) and then implanting 24mm cementless glenoid baseplate, +6mm post extension, 40mm centered glenosphere with screw, 135/145 40/+3 standard humeral cup, and 4 screws.

• Brand Name: HUMERIS CEMENTLES ANATOMICAL
• Type of Device: UNCEMENTED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS SAS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12099758
• MDR Text Key: 259586104
• Report Number: 3014128390-2021-00037
• 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: 07/01/2021

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: N3232
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2021
• Distributor Facility Aware Date: 06/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2021
• 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: 63 YR