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

Catalog Number 103-0803

Device Problem Unstable (1667)

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

Event Date 08/11/2020

Event Type  Injury  

Event Description

Patient revised for third time on (b)(6) 2020 due to instability approximately two years after primary surgery.First revision on (b)(6) 2020 and second revision on (b)(6) 2020 were previously reported.Surgeon explanted a 36/+3 standard humeral cup and replaced it with a 36/+6 stability humeral cup.

• Brand Name: HUMERIS
• Type of Device: REVERSED SOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 10497056
• MDR Text Key: 205875341
• Report Number: 3014128390-2020-00058
• 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: 09/04/2020

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 Catalogue Number: 103-0803
• Device Lot Number: N2299
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2020
• Distributor Facility Aware Date: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2020
• 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: 56 YR