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	Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient had a revision on their left reverse total shoulder arthroplasty.This stem fractured which resulted in proximal humerus fracture which required a humeral reconstruction prosthesis (hrp) to be carried out.The stem, tray, liner and glenosphere were all revised and a hrp was put in.Patient was last known to be in stable condition following the event.Products not returning: hospital have not decontaminated.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): a10012 - gps implant kit v2, 03000623162; 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm, 5938765; 315-35-00 - glnd kwire, a389948; 320-15-05 - eq rev locking screw, a492735; 320-15-02 - rs glenoid plate sup aug, 10 deg, a546741; 320-20-00 - eq reverse torque defining screw kit, a561716; 320-01-38 - equinoxe reverse 38mm glenosphere, a594865; 320-10-00 - equinoxe reverse tray adapter plate tray +0, a726899; 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, a737505; 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, s445679; 320-20-42 - eq rev compress screw lck cap kit, 4.5 x 42mm, s450040; 320-38-00 - equinoxe reverse 38mm humeral liner +0, s484763.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h3: this event has been determined to be non-valid.The sales rep indicated that the fractured bone occurred secondary to a fall.

• 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 FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20796831
• Report Number: 1038671-2024-04538
• Device Sequence Number: 15144680
• Product Code: KWS
• UDI-Device Identifier: 10885862083340
• UDI-Public: 10885862083340
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/18/2025

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: 304-21-07
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: 69 YR
• Patient Sex: Female