MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REPLICATOR PLATE 1.5MM O/S; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	300-10-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cta humeral head short, 38mm - 310-21-38, 2668110; equinoxe, humeral stem primary, press fit 7mm - 300-01-07, 6697025; equinox square torque define screw drive kit - 300-20-02, 7094503.
Event or Problem Description
As reported, 8 days post op left shoulder replacement, this 75 y/o male patient was revised due to infection.The patient has no soft tissue left and the infection is coming out of the wound so he decided to remove everything completely and hope the infection and wound heal.Patient was last known to be in stable condition following the event.Patient has had other event that were captured in case-(b)(6)/ er ex-rev 248 and case-(b)(6)/ ex-rev 249.Devices are not returning.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The circumstance that clearly influenced the revision of the shoulder system was ongoing infection in the shoulder joint and deterioration of soft tissue.These devices are used for treatment not diagnosis.

• Brand Name: EQUINOXE REPLICATOR PLATE 1.5MM O/S
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14930222
• Report Number: 1038671-2022-00755
• Device Sequence Number: 13924859
• Product Code: KWT
• UDI-Device Identifier: 10885862079381
• UDI-Public: 10885862079381
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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: 05/27/2025
• Device Model Number: 300-10-15
• Device Catalogue Number: 300-10-15
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female