MAUDE Adverse Event Report: EXACTECH, INC. 36MM HUMERAL LINER +0 UNCONSTRAINED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-36-00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: serial number, item number and full description.(b)(6), 320-32-36 - expanded glenosphere, 36mm, for small reverse.(b)(6), 320-35-01 - small glenoid plate.(b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm.(b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0.
Event or Problem Description
As reported, the patient had an initial right tsa on (b)(6) 2020.The patient presented on (b)(6) 2023 and after initially doing well when put in a sling for fx 1 year ago, subject came to clinic (b)(6) 2021 with increased pain.Ct was ordered and shown that the fx had gone on to become a non-union.Subject going to follow up regarding treatment plan, and has not followed up since.The case report form indicates that this event is definitely not related to device, definitely not related to procedure.Outcome: continuing.

• Brand Name: 36MM HUMERAL LINER +0 UNCONSTRAINED
• Common Device Name: PROSTHESIS, SHOULDER, NON-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: 18109831
• Report Number: 1038671-2023-02745
• Device Sequence Number: 18155427
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

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 Expiration Date: 03/12/2022
• Device Catalogue Number: 320-36-00
• 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: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2017
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White