MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; REVERSED SHOULDER PROSTHESIS

Catalog Number 104-0809

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 10/26/2020

Event Type  Injury  

Event Description

Patient revised for second time on (b)(6) 2020 due to dislocation.Primary surgery occurred (b)(6) 2019, and first revision (previously reported) on (b)(6) 2020.Surgeon explanted 40/+9 standard humeral cup and 135/145 reversed adapter and then implanted a 40/+9 stability humeral cup, 135/145 reversed adapter, and +9mm humeral spacer.

• Brand Name: HUMERIS
• Type of Device: REVERSED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 10762275
• MDR Text Key: 213872758
• Report Number: 3014128390-2020-00076
• Device Sequence Number: 1
• Product Code: PHX
• 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: 10/30/2020

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: 10/01/2021
• Device Catalogue Number: 104-0809
• Device Lot Number: J1055
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2020
• Distributor Facility Aware Date: 10/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2020
• 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: 65 YR