MAUDE Adverse Event Report: EXACTECH, INC. 12.5MM PLATFORM FX STEM RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	304-22-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately one year post initial right tsa, the 63 y/o female patient had a revision due to periprosthetic fracture patient's stem, adapter tray and liner were exchanged.Surgeon used a hrp to rebuild the humerus.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation as they were disposed at the hospital.No other patient information/medical history reported.
Additional Manufacturer Narrative
Section d10: concomitant products: 12.5mm platform fx stem right (cat# 304-22-13 / serial# (b)(6)).Equinoxe reverse tray adapter plate tray +0 (cat# 20-10-00 / serial# (b)(6)).Eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical fracture cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were corrected: d1, d4, h4, h6 the revision reported was likely due to a bone fracture.The reason for the fracture cannot be conclusively determined but may be related to implant positioning, patient bone quality, a trauma, and/or another patient related condition.However, this cannot be confirmed based on the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, g4 the revision reported was likely due to a bone fracture.The reason for the fracture cannot be conclusively determined but may be related to implant positioning, patient bone quality, a trauma, and/or another patient related condition.However, this cannot be confirmed based on the information provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: 12.5MM PLATFORM FX STEM RIGHT
• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 17671576
• Report Number: 1038671-2023-02136
• Device Sequence Number: 6531413
• Product Code: KWT
• UDI-Device Identifier: 10885862083418
• UDI-Public: 10885862083418
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/01/2025

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 Model Number: 304-22-13
• Device Catalogue Number: 304-22-13
• Device Lot Number: 5041024
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 01/03/2024; 08/15/2025; 12/01/2025
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 04/18/2024; 08/20/2025; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• 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: 36MM GLENOSPHERE.; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM.; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM.; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM.; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM.; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM.; EQ REV GLENOID PLATE.; EQ REV LOCKING SCREW.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female