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

Model Number DIAMETER 39 mm OFFSET

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number (b)(4).

Event Description

Patient revised on (b)(6) 2021 due to rotator cuff tear from fall, following primary surgery on (b)(6) 2020.Surgeon converted anatomic to a reverse, explanting all components except stem (3-4 peg glenoid size s, 39x15 offset cocr head, +0mm double taper), and then implanting a 135/145 32/+3 standard humeral cup, 32mm centered glenosphere with screw, 24mm cementless glenoid baseplate, and 4 locking screws.

• Brand Name: HUMERIS CEMENTLESS ANATOMICAL
• Type of Device: UNCEMENTED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: ludovic badey ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12279185
• MDR Text Key: 265130459
• Report Number: 3009532798-2021-00108
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300466
• UDI-Public: 03701037300466
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/04/2021

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 Expiration Date: 11/01/2023
• Device Model Number: DIAMETER 39 mm OFFSET
• Device Catalogue Number: 106-3900
• Device Lot Number: L1789
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR