MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROTHESIS

Catalog Number 106-4600

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.

Event Description

Revision surgery due to a cuff tear occurred (b)(6) 2020.46 eccentric head was removed and replaced by 135/145 36/+3 humeral cup, 36 glenosphere, glenoid baseplate and associated screws.Date of primary surgery is unknown.

• Brand Name: HUMERIS
• Type of Device: SHOULDER PROTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: cedric joly ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 10458642
• MDR Text Key: 204514553
• Report Number: 3009532798-2020-00386
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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 Catalogue Number: 106-4600
• Device Lot Number: M1077
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2018
• 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