MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE SUP AUG, 10 DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-02
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 months and 7 days post the initial right reverse total shoulder arthroplasty, x-ray showed migration of the augment and glenosphere.Upon opening the patient, superior fracture of the glenoid was discovered.All implants were removed; there was no damage noted to any implants.A press fit stem retained and cta hemi were implanted.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3, h6 type of investigation, investigation findings, investigation conclusions.The following sections were corrected: h6 problem code, component code.H3: the revision reported may have been due to glenoid component migration secondary to a displaced bone fracture.There is no allegation or clear indication that the baseplate or screws were independently loosened from the bone prior to the reported bone fracture.However, the migration and fracture could not be confirmed from the single provided ct view.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 and relevant clinical information were not provided.
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10: (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6), 320-15-05 - eq rev locking screw; (b)(6), 320-20-30 - 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), 320-20-00 - eq reverse torque defining screw kit; (b)(6), 320-38-00 - equinoxe reverse 38mm humeral liner +0; (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere; (b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm; (b)(6), 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm; (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.

• Brand Name: RS GLENOID PLATE SUP AUG, 10 DEG
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21652559
• Report Number: 1038671-2025-01631
• Device Sequence Number: 9235264
• Product Code: KWS
• UDI-Device Identifier: 10885862186676
• UDI-Public: 10885862186676
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: 320-15-02
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2024
• 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: Hospitalization
• Patient Sex: Male