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	Insufficient Information (4580)
Date of Event	05/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) reported concomitant device(s): 320-36-00 - 145-deg pe 36mm hum liner +0: (b)(6) 320-10-00 - equinoxe reverse tray adapter plate tray +0: (b)(6) 320-31-36 - glenosphere, 36mm: (b)(6) 320-35-02 - small superior augment glenoid plate: (b)(6).
Event or Problem Description
Approximately 1 year(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced aseptic humeral loosening of humeral component.The patient underwent fracture reverse revision with the reported removal of the torque screw, fracture humeral stem, humeral tray, humeral liner, and glenosphere.The outcome of this event is now considered resolved and the clinical report indicates that this event is definitely not related to the device(s) and definitely related to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
The revision reported may be the result of the humeral loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as the devices were not returned for evaluation and no images or radiographs were provided.D1: corrected.H6: corrected investigation clinical codes.

• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20612266
• Report Number: 1038671-2024-04246
• Device Sequence Number: 8164013
• 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: K101909
• 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
• 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: 304-22-09
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 06/02/2020
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American