MAUDE Adverse Event Report: EXACTECH, INC. SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-35-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Septic loosening (4884)
Date of Event	05/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) - 300-30-08 - equinoxe preserve stem 8mm.(b)(6) - 320-36-00 - 36mm humeral liner +0 unconstrained.(b)(6) - 320-10-00 - equinoxe reverse tray adapter plate tray +0.(b)(6) - 320-01-36 - 36mm glenosphere.(b)(6) - 320-15-05 - eq rev locking screw.(b)(6) - 320-20-00 - eq reverse torque defining screw kit.(b)(6) - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) - 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm.(b)(6) - 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm.(b)(6) - 315-35-00 - glnd kwire.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2022-00699.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 that the patient underwent an initial reverse total shoulder replacement on the left side.Approximately 25 months post-op, the patient experienced early pain from post-op allodynia/plexopathy.Subsequently the glenoid and humerus became septically loose.As a result, approximately 30 months after initial replacement, the patient underwent revision procedure.No further impact to the patient was reported.No other 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.The revision reported may be the result of septic glenoid and/or humeral loosening as reported.However, these failures cannot be confirmed as no relevant clinical information, images, or radiographs were provided.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: SMALL SUPERIOR/POSTERIOR AUG GLENOID PLATE,LEFT
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23027582
• Report Number: 1038671-2025-02909
• Device Sequence Number: 21253121
• Product Code: PHX
• UDI-Device Identifier: 10885862534910
• UDI-Public: 10885862534910
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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: 320-35-07
• 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: 05/31/2022
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 09/22/2025
• Date Device Manufactured: 10/01/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White