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

Catalog Number 105-3210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteopenia/ Osteoporosis (2651)

Event Date 05/13/2021

Event Type  Injury  

Event Description

Patient revised on (b)(6) 2021 due to poor bone quality approximately 4.5 months after primary surgery.Surgeon converted the reverse to a hemi, explanting all components except for the stem (32/+3 standard humeral cup, 32mm centered glenosphere with screw, 24mm glenoid baseplate, +6mm post extension, and 4 standard screws) and then implanting a 24/10 eccentric taper adapter and 43x16 cocr centered humeral head.

• 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: 11931279
• MDR Text Key: 254239570
• Report Number: 3014128390-2021-00033
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 105-3210
• Device Lot Number: N3245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2021
• Distributor Facility Aware Date: 05/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2021
• 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: 67 YR