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

Catalog Number 105-3610

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 03/09/2021

Event Type  Injury  

Event Description

Patient revised for the second time on (b)(6) 2021 due to dislocation from non-compliance with post-operative instructions, approximately 5 days after first revision (poly swap due to noncompliance; exchanged 36/+3 standard cup for 36/+6 stability cup) and 3 weeks after primary surgery.Surgeon explanted the 36/+6 stability humeral cup and 36mm centered glenosphere with screw, and replaced them with a 36/+9 stability humeral cup and 36mm eccentric glenosphere with screw.

• Brand Name: HUMELOCK REVERSED
• Type of Device: REVERSED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11498144
• MDR Text Key: 240339343
• Report Number: 3014128390-2021-00012
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 105-3610
• Device Lot Number: N3427
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2021
• Distributor Facility Aware Date: 03/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR