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

Catalog Number 108-4520

Device Problem Crack (1135)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 02/24/2020

Event Type  malfunction  

Event Description

As surgeon was tightening down baseplate locking screw size 20 during reverse surgery on (b)(6) 2020, the screw head formed crack down the middle.As they attempted to remove screw, crack worsened and surgeon was unable to secure a screwdriver into the screw.Surgeon made decision to leave screw in.Surgeon communicated to field representative that they took extra precautions to prevent infection.

• Brand Name: HUMERIS
• Type of Device: REVERSED SHOULDER PROTHESIS
• 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: cedric joly ; 1663 rue de majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 9847653
• MDR Text Key: 188263338
• Report Number: 3009532798-2020-00145
• Device Sequence Number: 1
• Product Code: PHX
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 108-4520
• Device Lot Number: N1935
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR