MAUDE Adverse Event Report: EXACTECH, INC. SPECIFIC DEVICE NOT REPORTED; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-35-06
Medical Device Problem Codes	Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 320-31-36 - glenosphere, 36mm: 6677425, 320-36-00 - 145-deg pe 36mm hum liner +0: 6555478, 320-10-00 - equinoxe reverse tray adapter plate tray +0: 6758888, 320-15-05 - eq rev locking screw: 6749251, 320-20-00 - eq reverse torque defining screw kit: 6738080, 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: s103174, 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: s213774, 320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: s123484, 321-20-00 - equinoxe reverse shoulder drill kit: 6785071.
Event or Problem Description
Approximately 1 year, 7 months.And 7 days after an initial left tsa, the patient dislocated the shoulder due to recurrent instability episodes over 2 years.3 years and 5 months after initial implantation, the patient underwent standard reverse with preserve stem revision and the event is considered resolved.The case report indicates that the event is possibly related to device(s) and/or to the procedure.
Additional Manufacturer Narrative
D1: corrected d4/d6: device, serial #, udi #, expiration, implant and explant dates unknown.G3: manufactured dates unknown.G4: pma 510k cannot be determined.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: SPECIFIC DEVICE NOT REPORTED
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19630124
• Report Number: 1038671-2024-02198
• Device Sequence Number: 12535993
• Product Code: KWT
• UDI-Device Identifier: 10885862086617
• UDI-Public: 10885862086617
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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: 320-35-06
• 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: 06/15/2024
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/31/2025
• Date Device Manufactured: 03/25/2019
• 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.
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Race: White