MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR AUGMENT GLENOID PLATE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 320-35-02

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): serial #: (b)(6), category #: 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, serial #: (b)(6), category #: 320-15-05 - eq rev locking screw, serial #: (b)(6), category #: 320-36-00 - 145-deg pe 36mm hum liner +0, serial #: (b)(6), category #: 320-10-00 - equinoxe reverse tray adapter plate tray +0, serial #: (b)(6), category #: 315-35-00 - glnd kwire, serial #: (b)(6), category #: 320-20-00 - eq reverse torque defining screw kit, serial #: (b)(6), category #: 300-30-06 - equinoxe preserve stem 6mm, serial #: (b)(6), category #: 321-20-00 - equinoxe reverse shoulder drill kit, serial #: (b)(6), category #: 320-31-36 - glenosphere, 36mm, serial #: (b)(6), category #: 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, serial #: (b)(6), category #: 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, serial #: (b)(6), category #: 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm.

Event Description

As reported, approximately 2 years post op initial left tsa, this 38 y/o female patient's was revised.The patients glenohumeral joint grew very lax over time and surgeon elected to upsize all possible components.

• Brand Name: SMALL SUPERIOR AUGMENT GLENOID PLATE
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16869656
• MDR Text Key: 314619065
• Report Number: 1038671-2023-00907
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862534873
• UDI-Public: 10885862534873
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-35-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2020
• 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 Age: 38 YR
• Patient Sex: Female