MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 38MM HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-38-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 300-01-15 - eq humeral stem primary, press fit 15mm: (b)(6); 320-06-38 - glenosphere 38mm: (b)(6); 320-10-00 - eq rev tray adapter plate tray: +0: (b)(6); 320-15-01 - eq rev glenoid plate: (b)(6); 320-15-05 - eq rev locking screw: (b)(6); 320-20-00 - eq rev torque defining scrw kit: (b)(6); 320-20-22 - eq rev cmprss scrw lck cap kit, 4.5 x 22mm: (b)(6); 320-20-30 - eq rev cmprss scrw lck cap kit, 4.5 x 30mm: (b)(6); 320-20-38 - eq rev cmprss scrw lck cap kit, 4.5 x 38mm: (b)(6); 320-20-38 - eq rev cmprss scrw lck cap kit, 4.5 x 38mm: (b)(6); 315-35-00 - glnd kwire: (b)(6); 201-78-89 - 3" drill bit, mod.Hex 2 pack: (b)(6); 321-20-00 - eq rev shoulder drill kit: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, a party stated her husband underwent right shoulder replacement surgery and that they experienced pain and an infection.No further information available.
Additional Manufacturer Narrative
A review of the sterile certificates and/or the final endotoxin test reports was performed.All lots were accepted to the requirements.The reason for the reported revision due to suspected infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the surgical procedure.D1: corrected h6: corrected investigation clinical codes.

• Brand Name: 145-DEG PE 38MM HUM LINER +0
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21517786
• Report Number: 1038671-2025-01390
• Device Sequence Number: 8454910
• Product Code: KWT
• UDI-Device Identifier: 10885862086655
• UDI-Public: 10885862086655
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• 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 Expiration Date: 05/05/2026
• Device Catalogue Number: 320-38-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 05/13/2021
• 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: 69 YR
• Patient Sex: Male