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

Model Number	265152
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: ARROW GLENOSPHERE COCR D42
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 12342859
• Report Number: 3003898228-2021-00005
• Device Sequence Number: 19817904
• Product Code: KWS
• UDI-Device Identifier: 03661489651526
• UDI-Public: 03661489651526
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/21/2021

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
• Operator of Device: No Information
• Device Expiration Date: 06/23/2020
• Device Model Number: 265152
• Device Lot Number: E04703
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention