MAUDE Adverse Event Report: FH INDUSTRIE ARROW; ARROW GELNOSPHERE COCR D39

Model Number 265151

Device Problem Material Separation (1562)

Patient Problem Implant Pain (4561)

Event Date 10/01/2020

Event Type  malfunction  

Event Description

The patient complained of shoulder pain and said he was playing with his dog and felt something was not right.Upon further examination it was determined that glenosphere had dislodged from baseplate and cap screw was broken.Revision was scheduled for (b)(6) 2021.Tha patient was revised on (b)(6) 2021.Baseplate, glenosphere, broken screw and humeral insert were removed.Stem remained in place.Revised glenoid with a djo baeseplate and 36 djo glenosphere.Inserted fh 36/00 humeral insert.

• Brand Name: ARROW
• Type of Device: ARROW GELNOSPHERE COCR D39
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• Manufacturer (Section G): FH INDUSTRIE; 6 reu nobel; quimper, 29000 ; FR 29000
• Manufacturer Contact: cécilia hernoux ; 3 rue de la foret; heimsbrunn, 68990 ; FR 68990
• MDR Report Key: 12342858
• MDR Text Key: 267288920
• Report Number: 3003898228-2021-00006
• Device Sequence Number: 1
• Product Code: KWS
• 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: 12/28/2020
• Device Model Number: 265151
• Device Lot Number: F03103
• 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