MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROSTHESIS

Catalog Number 910-0209

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 10/16/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019, the surgeon reamed to a 9mm broach and the implant sat proud.The surgeon reamed to a 10mm broach and implanted a size 9 humeris stem, which delayed the surgery by about 45 minutes.

• Brand Name: HUMERIS
• Type of Device: SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: samantha sterling ; 13465 midway rd; suite 101; dallas, TX 75244 ; 2148904109
• MDR Report Key: 9401588
• MDR Text Key: 189626807
• Report Number: 3014128390-2019-00049
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 910-0209
• Device Lot Number: M3008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization