MAUDE Adverse Event Report: EXACTECH, INC. EQ REV GLENOID PLATE; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	320-15-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Joint Laxity (4526)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 315-35-00 - glnd kwire (b)(6) 315-35-00 - glnd kwire (b)(6) 320-01-38 - equinoxe reverse 38mm glenosphere (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6) 320-15-01 - eq rev glenoid plate (b)(6) 320-15-05 - eq rev locking screw (b)(6) 320-20-00 - eq reverse torque defining screw kit (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6) 320-38-00 - equinoxe reverse 38mm humeral liner + 0 (b)(6) 531-20-00 - shldr gps rvrs drill kit.(b)(6) 531-78-20 - shouldr gps hex pins kit.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported approximately 78 months after a left shoulder arthroplasty the patient underwent a revision procedure to address loosening.It was noted post operatively the stem and glenoid components were loose, and the surgeon elected to remove all of the shoulder components.The patient was a revised to exactech devices.No surgical or medical interventions were reported.The patient was last known to be in stable condition following the event.No additional information is available.
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.The revision reported may be the result of the glenoid loosening and stem loosening as reported.The humeral stem loosening may have been due to loss of fixation over time.Additionally, the glenoid baseplate loosening may have been the result of loss of fixation between the compression screws and the patient¿s native glenoid bone, an unreported fracture of the compression screws, or an unreported traumatic event.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 relevant clinical information was provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, g4, h4, h6 mdr section codes updated/corrected: e 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, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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
• MDR Report Key: 22072790
• Report Number: 1038671-2025-02127
• Device Sequence Number: 8711797
• Product Code: HSD
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 10/22/2025

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?: Yes
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 10/21/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 10/22/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female