MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID S, POST AUG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device return anticipated.Device remains implanted.Concomitants medical devices: 300-10-45 - equinoxe replicator plate 4.5mm o/s sn: (b)(4), 300-20-02 - equinox square torque define screw drive kit sn: (b)(4), 300-30-06 - equinoxe preserve stem 6mm sn: (b)(4), 310-02-44 - equinoxe, humeral head tall, 44mm (alpha) sn: (b)(4), 321-20-00 - equinoxe reverse shoulder drill kit sn: (b)(4), 531-78-20 - shouldr gps hex pins kit sn: (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a female patient, initially implanted on (b)(6) 2018, presented to the clinic with a painful right shoulder.X-ray imaging show peg failure per the surgeon.Revision surgery has been recommended but has not occurred.
Additional Manufacturer Narrative
Duplicate case.See 1038671-2022-01354.
Event or Problem Description
The revision occurred and has been reported under 1038671-2022-01354.This case is a duplicate.

• Brand Name: EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15294414
• Report Number: 1038671-2022-00969
• Device Sequence Number: 12321409
• Product Code: KWS
• UDI-Device Identifier: 10885862201003
• UDI-Public: 10885862201003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2021
• Device Model Number: EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
• Device Catalogue Number: 314-13-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female