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

Model Number	SMALL SUPERIOR AUGMENT GLENOID PLATE
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Periprosthetic fracture (4902)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: (b)(4), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (b)(4), 315-35-00 - glnd kwire, (b)(4), 320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(4), 320-15-05 - eq rev locking screw, (b)(4), 320-20-00 - eq reverse torque defining screw kit, (b)(4), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(4), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(4), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, (b)(4), 320-31-40 - glenosphere, 40mm, 320-40-03 humeral liner, 40mm, +2.5 7094722.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that a 71 yo female patient, initial left shoulder implanted on (b)(6) 2022, with no complications, ¿post op x-rays looked perfect¿, underwent a revision procedure on (b)(6) 2022.The x-rays showed that the implant had either rotated superiorly or migrated up.The doctor removed the liner, and then removed the glenosphere and all three screws from the baseplate.He then removed the superior baseplate and found that the top 1/3 superior/posterior had fractured resulting in the baseplate migrating superior.The doctor decided to switch to a tornier baseplate and used a 39 glenosphere.On the humoral side, the stem and +0 tray were well fixed so he trailed with a 40 +2.5 liner but wanted a little more constraint so went with a 40+2.5 liner.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
H6: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision due to scapular fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d9, h3, h6 clinical code, component code, type of investigation, investigation conclusion codes.Product has been received by exactech and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: SMALL SUPERIOR AUGMENT GLENOID PLATE
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 15729741
• Report Number: 1038671-2022-01401
• Device Sequence Number: 16862081
• Product Code: KWS
• UDI-Device Identifier: 10885862534873
• UDI-Public: 10885862534873
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 11/10/2025

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 Model Number: SMALL SUPERIOR AUGMENT GLENOID PLATE
• Device Catalogue Number: 320-35-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 02/02/2023; 11/10/2025
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 02/27/2023; 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female