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	Pain (1994)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitants: serial number item number and full description.(b)(6), 320-36-00 - 145-deg pe 36mm hum liner +0, (b)(6), 320-10-05 - equinoxe reverse tray adapter plate tray +5, (b)(6), 320-31-36 - glenosphere, 36mm, (b)(6), 304-22-09 - 8.5mm platform fx stem right, (b)(6), 320-35-01 - small glenoid plate.The reason for the revision reported cannot be confirmed from the information provided but may be the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.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 and radiographs were 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 that approximately 23 months after a total shoulder replacement procedure, the patient underwent a revision procedure to address loosening and pain.Patient left the operating room in stable condition.No further issues or complications were 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 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 22124465
• Report Number: 1038671-2025-02214
• Device Sequence Number: 20688324
• Product Code: KWS
• UDI-Device Identifier: 10885862083395
• UDI-Public: 10885862083395
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 10/31/2023
• Initial Report FDA Received Date: 06/02/2025
• Date Device Manufactured: 10/05/2021
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White