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

Catalog Number	320-46-03
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	04/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: pending investigation.D10: (b)(6); 300-30-10 - equinoxe preserve stem 10mm.(b)(6); 320-46-00 - 145-deg pe 46mm hum liner +0.(b)(6); 320-10-10 - equinoxe reverse tray adapter plate tray +10.(b)(6); 320-06-46 - glenosphere 46mm.(b)(6); 320-15-05 - eq rev locking screw.(b)(6); 320-20-00 - eq reverse torque defining screw kit.
Event or Problem Description
It was reported that this 64 y/o male patient's left shoulder was revised approximately 1 year 3 months post op initial surgery due to instability then again 1 year after that surgery.Patient had his original case done (b)(6) 2022 and was revised on (b)(6) 2023 and again during our case (b)(6) 2024.Doctor removed all implants and implanted all new implants.Patient was last known to be in stable condition following the event.
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, medical device, 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19244302
• Report Number: 1038671-2024-01053
• Device Sequence Number: 17995138
• Product Code: KWT
• UDI-Device Identifier: 10885862086747
• UDI-Public: 10885862086747
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• 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): 07/30/2025

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: 320-46-03
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2022
• 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: Male