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

Catalog Number	304-21-09
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tsa on (b)(6) 2023.The patient was revised on (b)(6) 2024 as a result of a dislocation due to a loose stem.The patient was revised to a +0 adapter tray, a 36mm liner, and the screw kit was also revised.The fracture stem was revised to a 8.5mm.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
H3: pending investigation.D10: a701687 - 320-10-00 - equinoxe reverse tray adapter plate tray +0, a720232 - 320-15-05 - eq rev locking screw, a706911 - 320-20-00 - eq reverse torque defining screw kit s094540 - 320-20-22 - eq rev , compress screw lck cap kit, 4.5 x 22mm, a676168 - 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, s436366 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm , s471847 - 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm , a375928 - 320-31-36 - glenosphere, 36mm , a711223 - 320-35-01 - small glenoid plate , a685448 - 304-21-09 - 8.5mm platform fx stem left , a456407 - 321-52-07 - 3.2mm drill bit sterile , a610188 - 321-52-09 - 3.2mm k-wire, trocar tip.
Additional Manufacturer Narrative
The revision reported was likely the result of an insufficient bond between the humeral stem and the bone which led to humeral loosening and dislocation.The extent and root cause of the humeral loosening and dislocation could not be determined as the devices were not returned for evaluation, and images and radiographs were not provided.
Additional Manufacturer Narrative
(b)(6).- 320-36-00 - 36mm humeral liner +0 unconstrained.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported may have been due to an insufficient bond between the humeral stem and the bone which led to humeral loosening and dislocation.However, the reported humeral loosening and dislocation could not be confirmed, and the sequence of events could not be determined from the reported information.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, radiographs, and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 8.5MM PLATFORM FX STEM LEFT
• 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: michael crader ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18757300
• Report Number: 1038671-2024-00287
• Device Sequence Number: 19792704
• Product Code: KWS
• UDI-Device Identifier: 10885862083357
• UDI-Public: 10885862083357
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/21/2025

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: 304-21-09
• 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: 01/31/2024
• Supplement Date Received by Manufacturer: 05/10/2024; Not provided; 05/20/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/12/2024; 05/14/2024; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2023
• 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 H10; SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female