MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROTHESIS

Model Number 106-3900

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 09/01/2020

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 on (b)(6) 2020.Double tapper, 3-4 pegs glenoid pe, ø39 eccentric head were removed and replaced by glenoid baseplate, ø36 eccentric glenosphere, ø36/+3 135/145 standard humeral cup and associated screws.

• 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: cédric joly ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 10501208
• MDR Text Key: 205886627
• Report Number: 3009532798-2020-00407
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/08/2020

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: 06/01/2023
• Device Model Number: 106-3900
• Device Lot Number: M2163
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2018
• 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