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

Catalog Number	314-13-13
Medical Device Problem Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Medical device site infection (4845); Aseptic loosening (4883)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 300-30-10 - equinoxe preserve stem 10mm: 5582373 300-50-45 - 4.5mm short rep plate: 5416244 310-01-47 - equinoxe, humeral head short, 47mm (beta): 5193690 315-35-00 - glnd kwire: 5665042 300-20-02 - equinox square torque define screw drive kit: 5442999.
Event or Problem Description
As reported by the equinoxe shoulder study, the 56-year-old male patient had an initial right tsa on (b)(6) 2018 and presented with polyethylene wear (with or without osteolysis), approximately 1 month(s) and 5 year(s) post-operatively on 15-nov-2023.Reviewing x-rays and patient has poly wear.Patient also has increase in pain.The outcome of this event is considered continuing, with the action taken of other - monitoring with x-ray as patient did not want to proceed with revision intervention immediately.The case report form indicates that this event is definitely related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Event or Problem Description
Approximately 5 year(s) and 20 day(s) post-operatively of initial implantation of a right tsa, it was reported via clinical trial study that the patient presented with polyethylene wear (with or without osteolysis).X-rays and monitoring showed and lead to the patient seeking a standard total with preserve stem revision 10 months later, in which the stem and glenoid were replaced.During the surgery, it was reported deep infection with aseptic glenoid loosening.The outcome of this event is now considered resolved, and the case report form indicates that this event is definitely related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitants: 300-30-10 - equinoxe preserve stem 10mm: 5582373; 300-50-45 - 4.5mm short rep plate: 5416244; 310-01-47 - equinoxe, humeral head short, 47mm (beta): 5193690; 315-35-00 - glnd kwire: 5665042; 300-20-02 - equinox square torque define screw drive kit: 5442999.This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b2, d6b, g1-contact first/last name, h6 - clinical codes, medical device problem code, component code, type of investigation, investigation findings, and investigation conclusions.The following sections were corrected: b5, d10, h6 - impact codes.No device was returned for evaluation; the reported event was confirmed by review of photographs and radiograph images of the device.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: h6: health effect - clinical code, health effect - impact code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusions multiple mdr reports were filed for this event, please see associated reports: 1038671-2025-01893.The pain and subsequent revision reported may be the result of the aseptic glenoid loosening, prosthesis wear, and infection as reported.However, the failures cannot be confirmed as no relevant clinical information, images, or radiographs were provided.Potential contributions of manufacturing, patient, or user-related issues to the event cannot be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, BETA
• 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: goeff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18810107
• Report Number: 1038671-2024-00349
• Device Sequence Number: 20903578
• Product Code: KWS
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2025

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: 01/28/2021
• Device Catalogue Number: 314-13-13
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 01/17/2025; 05/22/2025
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 01/18/2025; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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.; SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White