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

Catalog Number	314-02-14
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Medical device site infection (4845)
Date of Event	08/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 300-01-15 - equinoxe, humeral stem primary, press fit 15mm: 7160491, 310-01-50 - equinoxe, humeral head short, 50mm (beta): 7169429, 300-10-15 - equinoxe replicator plate 1.5mm o/s: 6882731.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Approximately 6 month(s) and 26 day(s) post-operative of a right tsa, it was reported via clinical study that the patient experienced septic loosening with severe pain.The patient underwent a standard total revision for the loosening with the reported removal of the glenoid component.The outcome of this event is considered resolved and the case report form indicates that this event is possibly related to the device and definitely related to the procedure.This was reported through clinical trial study data collection activities, no device return is anticipated, and no other information is available at this time.
Additional Manufacturer Narrative
The revision reported may be the result of the glenoid loosening as reported.However, the loosening cannot be confirmed and any potential contributions from user or patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.The reason for the infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the surgical procedure.A review of the sterile certificate was performed and the sterile lot was accepted to the requirements.H6: corrected health effect, component, and investigation clinical codes.

• Brand Name: EQUINOXE GLENOID, PEGGED BETA, LARGE
• 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
• MDR Report Key: 21087933
• Report Number: 1038671-2025-00105
• Device Sequence Number: 17867168
• Product Code: KWS
• UDI-Device Identifier: 10885862084521
• UDI-Public: 10885862084521
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: 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 Expiration Date: 12/10/2023
• Device Catalogue Number: 314-02-14
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 06/24/2025
• Date Device Manufactured: 12/12/2018
• 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: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 114 KG
• Patient Race: White