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 Code	Insufficient Information (4580)
Date of Event	09/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10): concomitant device(s): 300-01-15 - equinoxe, humeral stem primary, press fit 15mm: 5800029 implant date: on (b)(6) 2019).320-10-00 - equinoxe reverse tray adapter plate tray +0: 6152915.320-15-01 - eq rev glenoid plate: 6174681.320-15-05 - eq rev locking screw: 6152475.320-38-00 - equinoxe reverse 38mm humeral liner +0: 6151762.
Event or Problem Description
Approximately 11 month(s) and 21 day(s) post-operative of a previously revised left rtsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.X-rays showed a loose glenoid screw, and further imaging showed loosening of the glenoid.The previous revision was due to a subscapularis tear of the rotator cuff.The patient underwent a standard reverse revision with the removal of the humeral tray, humeral liner, glenosphere and glenoid base plate.The outcome of this event is considered resolved and the clinical report indicates that this event is possibly related to the device(s) and/or to the procedure.
Additional Manufacturer Narrative
The revision reported may have been due to glenoid or screw loosening.However, 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.

• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20402089
• Report Number: 1038671-2024-03868
• Device Sequence Number: 6545813
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 320-15-01
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 04/22/2025
• Date Device Manufactured: 06/24/2019
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Race: White