MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW GLENOSPHERE COCR D42

Model Number 265152

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

The patient admitted to a traumatic event (fall) earlier in (b)(6) and upon examination, dr.(b)(6) determined glenosphere had dislodged from metal back baseplate.Revision to take place (b)(6) 2021.

• Brand Name: ARROW
• Type of Device: ARROW GLENOSPHERE COCR D42
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: cécilia hernoux ; 3 rue de la foret; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 12342859
• MDR Text Key: 267284605
• Report Number: 3003898228-2021-00005
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03661489651526
• UDI-Public: 03661489651526
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/23/2020
• Device Model Number: 265152
• Device Lot Number: E04703
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Required Intervention