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

Catalog Number	320-15-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Joint Dislocation (2374)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 4 years post op initial rtsa, this 73 y/o female patient was revised due to aseptic glenoid loosening.Rtsa glenoid loosening first noted (b)(6) 2021.Worsening pain and eventual dislocation on (b)(6) 2023.The case report form indicates this event is unlikely related to devices and definitely related to procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation: (d10) concomitant medical product: (b)(6).320-01-38 - equinoxe reverse 38mm glenosphere (b)(6).300-01-09 - equinoxe, humeral stem primary, press fit 9mm, (b)(6).320-10-00 - equinoxe reverse tray adapter plate tray +0 ,(b)(6).320-15-07 - sup/post aug plate, l rs glenoid baseplate.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, g3/g4, h4, h6.Mdr section codes updated/corrected: b, c, d, e.The revision reported may be the result of the glenoid loosening and joint dislocation as reported.However, the loosening and joint dislocation cannot be confirmed, or the possible sequence of events, from the information provided.The joint dislocation may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risk, as outlined in the ifu.Potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.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, L 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17644787
• Report Number: 1038671-2023-02086
• Device Sequence Number: 15349800
• Product Code: KWS
• UDI-Device Identifier: 10885862242556
• UDI-Public: 10885862242556
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 320-15-07
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White