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

Catalog Number	300-01-14
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via clinical study, that approximately 13 days postop the initial implant, this 43 yo male patient was revised due to a deep infection.The patient¿s outcome was last known as resolved.Devices will not be returned.
Additional Manufacturer Narrative
Concomitant medical products: serial number; item number and full description.(b)(6) - glenosphere exp 42mm +4mm offset, (b)(6) - equinoxe reverse tray adapter plate tray +0, (b)(6) - eq rev glenoid plate, (b)(6) - 145-deg pe 42mm hum liner +2.5.
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 infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the surgical procedure.D1: corrected d4/d6: device, serial #, udi #, device expiration 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 32563
• Manufacturer Contact: geoff gannon ; gainesville, FL 32653
• MDR Report Key: 17597797
• Report Number: 1038671-2023-02011
• Device Sequence Number: 17752318
• Product Code: KWS
• UDI-Device Identifier: 10885862283023
• UDI-Public: 10885862283023
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• 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: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 300-01-14
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2019
• 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 H10.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Race: White