MAUDE Adverse Event Report: EXACTECH, INC. UNKNOWN SHOULDER COMPONENT; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	300-01-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: as reported, the male patient had an equinoxe stem and competitor's custom glenoid component implanted in her right shoulder in 2016 and multiple infections over the years.The patient was revised on (b)(6) 2023.Everything was removed and a spacer was placed in-situ.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Event or Problem Description
As reported, the male patient had an equinoxe stem and competitor's custom glenoid component implanted in her right shoulder in 2016 and multiple infections over the years.The patient was revised on (b)(6) 2023.Everything was removed and a spacer was placed in-situ.There was no reported breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
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 the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Correction to d10: 4573116 320-10-00 - equinoxe reverse tray adapter plate tray +0, 4494183 320-20-00 - eq reverse torque defining screw kit, 4494399 320-42-00 - equinoxe reverse 42mm humeral liner +0.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4 (remove all from the initial report-suspect device unknown), d8, f6 & f9 (remove erroneous entries from initial report), g2 (australia), g4 (remove 501k from the initial report-unknown) h4 (remove erroneous entry on initial report), h6: health effect clinical code, health effect- impact code, type of investigation and investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: UNKNOWN SHOULDER COMPONENT
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 16782146
• Report Number: 1038671-2023-00779
• Device Sequence Number: 14237614
• Product Code: HSD
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2026

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: 05/24/2026
• Device Model Number: 300-01-15
• Device Catalogue Number: 300-01-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 02/27/2026
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 06/29/2023; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2016
• 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 Age: 66 YR
• Patient Sex: Male