MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE COMPONENT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-06-42
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) reported concomitant device(s): 300-30-08 - equinoxe preserve stem 8mm: a193229, 320-10-00 - equinoxe reverse tray adapter plate tray +0: a071443, 320-15-01 - eq rev glenoid plate: a213855, 320-42-00 - 145-deg pe 42mm hum liner +0: a199997.
Event or Problem Description
Approximately 1 year(s), 8 month(s) and 5 day(s) post-operative of a left rtsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening with shoulder pain and infection.Approximately 3 months following the onset of symptoms, the patient received a steroid injection and aspiration.The outcome of this event is considered continuing, and the clinical report indicates that the event is possibly related to the device(s) or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Corrected fields: a2(delete d.O.B.), b2, b3, d1, d4(delete all), g4(delete date), h4 (delete date), g6-medical device problem code.

• Brand Name: EQUINOXE COMPONENT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20654024
• Report Number: 1038671-2024-04334
• Device Sequence Number: 12455569
• Product Code: KWS
• UDI-Device Identifier: 10885862563712
• UDI-Public: 10885862563712
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K193098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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: 320-06-42
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2022
• 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 H11.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White