MAUDE Adverse Event Report: FH INDUSTRIE ARROW; GLENOSPHÈRE COCR Ø36

Catalog Number 260566

Device Problem Misassembly by Users (3133)

Patient Problem No Information (3190)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

There are only ce references concerned in this incident.

Event Description

Installation of the metal-back implant without any problem.The surgeon was unable to place the glenosphere after several attempts.He changed the implants and the installation was carried out without any problems.

Event Description

Installation of the metal-back implant without any problem.The surgeon was unable to place the glenosphere after several attempts.He changed the implants and the installation was carried out without any problems.

• Brand Name: ARROW
• Type of Device: GLENOSPHÈRE COCR Ø36
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 9743588
• MDR Text Key: 200482785
• Report Number: 3003898228-2020-00001
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K112193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 260566
• Device Lot Number: J00839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other