MAUDE Adverse Event Report: EXACTECH, INC. 6.5MM PLATFORM FX STEM LEFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	304-21-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 320-01-38 - equinoxe reverse 38mm glenosphere (b)(6) 320-38-00 - equinoxe reverse 38mm humeral liner +0 (b)(6) 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (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) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6) 320-15-05 - eq rev locking screw (b)(6) 320-20-00 - eq reverse torque defining screw kit (b)(6) 320-15-01 - eq rev glenoid plate (b)(6) tpa-13 - cement restrictor xs (extra small, sz 13) (b)(6).
Event or Problem Description
As reported, approximately 8 years and 3 months post the initial left tsa, the proximal humerus has resorbed away and over time the stem has come loose from moving like a windshield wiper over time.The surgeon was able to remove the humeral construct with his hand.The 38mm glenosphere was explanted as well and re-implanted a 42mm glenosphere.An 8 x 175mm long revision stem was re-implanted in the humerus along with a +0mm tray and +2.5mm liner.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
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, e, g.The revision reported was likely due to aseptic humeral loosening resulting from bone loss around the proximal humerus.The cause of this bone loss could not be confirmed but may be due to an underlying patient condition.Potential contributions of user or patient-relation considerations could not be assessed as the devices were not returned for evaluation and no relevant clinical information was provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 6.5MM 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; 2320 nw 66th court; gainesville GU 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20404068
• Report Number: 1038671-2024-03883
• Device Sequence Number: 20452938
• Product Code: KWS
• UDI-Device Identifier: 10885862083340
• UDI-Public: 10885862083340
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 08/29/2025

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 Expiration Date: 09/18/2024
• Device Catalogue Number: 304-21-07
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2014
• 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
• Patient Age: 67 YR
• Patient Sex: Female