MAUDE Adverse Event Report: EXACTECH, INC. 8.5MM PLATFORM FX STEM RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	304-22-09
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) - 320-02-38 - rs expanded glenosphere 38mm, +4mm offset, (b)(6) - 320-15-01 - eq rev glenoid plate, (b)(6) - 320-15-05 - eq rev locking screw, (b)(6) - 320-38-00 - equinoxe reverse 38mm humeral liner +0, (b)(6) - 320-10-00 - equinoxe reverse tray adapter plate tray +0, (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) - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (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) - 321-20-00 - equinoxe reverse shoulder drill 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 in a clinical shoulder study that approximately 46 months after a right reverse total shoulder replacement, a patient underwent a revision procedure to address loosening of the stem.No further patient impact was reported.No additional information is available.

• Brand Name: 8.5MM PLATFORM FX STEM RIGHT
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22855639
• Report Number: 1038671-2025-02807
• Device Sequence Number: 8373184
• Product Code: KWS
• UDI-Device Identifier: 10885862083395
• UDI-Public: 10885862083395
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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: 304-22-09
• 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: 07/26/2025
• Initial Report FDA Received Date: 08/20/2025
• Date Device Manufactured: 08/18/2017
• 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: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic