MAUDE Adverse Event Report: EXACTECH, INC. SUP/POST AUG PLATE, R RS GLENOID BASEPLATE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-08
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Impingement (4834)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: (b)(6) - 300-30-07 - equinoxe preserve stem 7mm, (b)(6) - 315-35-00 - glnd kwire, (b)(6) - 315-35-00 - glnd kwire, (b)(6) - 320-01-38 - equinoxe reverse 38mm glenosphere 6198913 - 320-10-00 - equinoxe reverse, tray adapter plate tray +0, (b)(6) - 320-15-05 - eq rev locking screw, (b)(6) - 320-15-08 - sup/post aug plate, r rs glenoid baseplate, (b)(6) - 320-20-00 - eq reverse torque defining screw kit 6166816 - 320-20-30 - eq rev compress, screw lck cap kit, 4.5 x 30mm, (b)(6) - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(6) - 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, (b)(6) - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm , (b)(6)- 320-38-00 - equinoxe reverse 38mm humeral liner +0 5994207 - 321-20-00 - equinoxe, reverse shoulder drill kit.
Event or Problem Description
As reported, the patient had an initial right rtsa on (b)(6) 2019.The patient was revised on (b)(6) 2023 due to glenoid loosening and evidence of notching.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
User-related considerations: there were no user-related issues reported that appear to have contributed to the reported event.Patient-related considerations: there are no patient conditions reported that appear to have contributed to the reported event.The reason for the revision reported cannot be confirmed from the information provided but may be the result of glenoid loosening.The reported glenoid loosening could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6 clinical code.

• Brand Name: SUP/POST AUG PLATE, R RS GLENOID BASEPLATE
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18197013
• Report Number: 1038671-2023-02851
• Device Sequence Number: 12363051
• Product Code: KWS
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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 Catalogue Number: 320-15-08
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• 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: 73 YR
• Patient Sex: Male