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

Catalog Number	320-15-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561); Medical device site infection (4845)
Date of Event	05/11/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 2 year(s) and 6 month(s) post implantation of left revised tsa, the patient presented with aseptic glenoid loosening.Despite ct, bone scan, dce surgery, patient has described current situation as "severe pain" in left shoulder.Patient is unable to use left shoulder for basic adls.States any motion causes pain.Pain is sharp, not improving and present at rest but more severe w/ motion.Pain not associated w/ tingling, numbness or weakness.The patient underwent a standard reverse revision followed by an abx spacer 2 months later, and the event is considered resolved.The clinical report indicates that the event is possibly related to the device(s) and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.Previous revision submitted under 1038671-2024-01814.
Additional Manufacturer Narrative
Pending investigation.D10: 320-01-42 - equinoxe reverse 42mm glenosphere: (b)(6).320-10-05 - equinoxe reverse tray adapter plate tray +5: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: (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).320-42-00 - equinoxe reverse 42mm humeral liner +0: (b)(6).321-20-00 - equinoxe reverse shoulder drill kit: (b)(6).13a2111 - cemex system fast genta 40g: (b)(6).652-00-05 - optecure with ccc - 5cc: (b)(6).Asa0030 - sterile disposable containers: (b)(6).Sps0021k - interspace shoulder kit 46mm: (b)(6).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, h6.Mdr section codes updated/corrected: b, c, d, e, f, g.The revision and pain reported was likely due to glenoid loosening and a possible infection.However, the reported glenoid loosening and infection could not be confirmed.Additionally, 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.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQ REV GLENOID PLATE
• Common Device Name: 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19568090
• Report Number: 1038671-2024-02002
• Device Sequence Number: 15194275
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/11/2023
• Device Catalogue Number: 320-15-01
• 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: 10/29/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 09/12/2013
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Race: White