MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID L, POST AUG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-34
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) reported concomitant device(s): 300-30-12 - equinoxe preserve stem 12mm: 5070264.310-00-53 - equinoxe, humeral head, extra short, 53mm: 4737738.300-50-15 - 1.5mm short rep plate: 4950568.
Event or Problem Description
Approximately 7 year(s) and 1 day(s) post-operative of a right tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.Patient began having pain and numbness without injury.The patient was administered medication, and the outcome of this event is considered continuing.The clinical report indicates that this event is definitely not related to the device(s) and/or to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
The pain reported may be the result of the glenoid loosening as reported.However, the glenoid loosening cannot be confirmed and the underlying reason and/or any contributing factors to the event cannot be confirmed as the devices remain implanted and no radiographs were provided.H6: corrected component, and investigation clinical codes.

• Brand Name: EQUINOXE CAGE GLENOID L, POST AUG, RIGHT
• 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: 20665250
• Report Number: 1038671-2024-04366
• Device Sequence Number: 17951574
• Product Code: KWS
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 02/28/2022
• Device Catalogue Number: 314-13-34
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 05/08/2025
• Date Device Manufactured: 03/01/2017
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White