MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH; SHOULDER PROTHESIS

Catalog Number 106-3900

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 05/20/2021

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 a dislocation occurred (b)(6) 2021.The dislocation happened due to false movement made by the physio during a rehabilitation session.Ø39 humeral head and double tapper were removed and replaced by ø39 humeral head and ø39+3 centered spaced.Primary surgery occurred (b)(6) 2021.

• Brand Name: EASYTECH
• Type of Device: SHOULDER PROTHESIS
• 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: marine le doujet ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11946174
• MDR Text Key: 254800326
• Report Number: 3009532798-2021-00092
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 106-3900
• Device Lot Number: N0360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2020
• 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