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

Model Number	304-22-09
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tsa on (b)(6) 2022.The patient was revised to a reverse shoulder on (b)(6) 2023 due to shoulder instability.During final reduction of reverse implants, the glenoid construct fixation failed due to poor bone quality.The reverse components were then removed and replaced with anatomic hemi components.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.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.306-02-08 equinoxe humeral long stem 8mm 215mm 3672963, 320-10-05 equinoxe reverse tray adapter plate tray +5 6895242, 320-15-05 eq rev locking screw a110277, 320-20-00 eq reverse torque defining screw kit a230272, 320-20-26 eq rev compress screw lck cap kit 4.5 x 26mm s407385, 320-20-26 eq rev compress screw lck cap kit 4.5 x 26mm s407384, 320-20-26 eq rev compress screw lck cap kit 4.5 x 26mm a209772, 320-20-42 eq rev compress screw lck cap kit 4.5 x a183542, 320-32-36 expanded glenosphere 36mm for small reverse 7007266, 320-36-00 36mm humeral liner +0 unconstrained a076781.
Additional Manufacturer Narrative
H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the instability and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
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: a, b, c, d, e, g.The cause of the patient's shoulder dislocation and subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risk, as outlined in the ifu.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 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16758732
• Report Number: 1038671-2023-00714
• Device Sequence Number: 16910154
• Product Code: KWS
• UDI-Device Identifier: 10885862083395
• UDI-Public: 10885862083395
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K092900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2025

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 Model Number: 304-22-09
• Device Catalogue Number: 304-22-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 07/21/2025
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 12/13/2023; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female