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 moving heavy washer/dryer units earlier in (b)(6) and upon examination,the doctor determined glenosphere had dislodged from metal back baseplate.Appears cap screw has sheared off and floating in shoulder.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: 12342867
• Report Number: 3003898228-2021-00004
• Device Sequence Number: 3938170
• 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: Lay User/Patient
• Device Expiration Date: 07/21/2022
• Device Model Number: 265152
• Device Lot Number: H01170
• 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