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	Bacterial Infection (1735); Pain (1994); Implant Pain (4561); Medical device site infection (4845)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): (b)(6): 320-06-38 - glenosphere 38mm.(b)(6): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm.(b)(6): 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6): 320-15-05 - eq rev locking screw.(b)(6): 320-20-00 - eq reverse torque defining screw kit.(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): 320-38-00 - 145-deg pe 38mm hum liner +0.(b)(6): 321-20-00 - equinoxe reverse shoulder drill kit.(b)(6): 531-20-00 - shldr gps rvrs drill kit.(b)(6): 531-78-20 - shouldr gps hex pins kit.(b)(6): a10012 - gps implant kit v2.
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 5 months post implantation of right tsa, the patient presented with septic loosening.At fall 2021 visit, subject said he was in a mva 2 months earlier and has had severe pain in shoulder ever since.X-ray images showed lucency around the glenoid cage & superior screw.Revision surgery is tbd.This event is still considered continuing, and the clinical report indicates that the event is definitely not related to the device(s) and possibly related to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e.The adverse event reported may be the result of the glenoid septic loosening as reported.However, the loosening cannot be confirmed and any potential contributions from user or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.The reason for the reported infection cannot be conclusively determined; however, it may be related to an underlying patient condition.A review of the sterile certificates was performed for all components.All lots were accepted to the requirements.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19481570
• Report Number: 1038671-2024-01750
• Device Sequence Number: 8010609
• Product Code: KWS
• UDI-Device Identifier: 10885862242563
• UDI-Public: 10885862242563
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K131575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 05/22/2024
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/03/2025
• Date Device Manufactured: 08/05/2020
• 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
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Hispanic