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

Catalog Number	314-13-23
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: a10012 - gps implant kit v2 11021019075 314-13-23 - equinoxe cage glenoid m, post aug, left 5951167 300-30-10 - equinoxe preserve stem 10mm 6107305 300-10-45 - equinoxe replicator plate 4.5mm o/s 6373379 300-20-02 - equinoxe square torque define screw drive kit 6405006 531-78-20 - shouldr gps hex pins kit 6411366.
Event or Problem Description
As reported, approximately 4 years and 6 months post the initial left tsa, the patient complained of pain and was revised due to aseptic loosening.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D1: corrected.D4: corrected.D10: concomitant devices: a10012 - gps implant kit v2 11021019075.300-30-10 - equinoxe preserve stem 10mm 6107305.300-10-45 - equinoxe replicator plate 4.5mm o/s 6373379.300-20-02 - equinox square torque define screw drive kit 6405006.531-78-20 - shouldr gps hex pins kit 6411366.G4: corrected.H6: corrected component, and investigation clinical codes.H10: corrected.

• Brand Name: EQUINOXE CAGE GLENOID M, POST AUG, LEFT
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20352327
• Report Number: 1038671-2024-03788
• Device Sequence Number: 18124375
• Product Code: KWS
• UDI-Device Identifier: 10885862196170
• UDI-Public: 10885862196170
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2024
• Device Catalogue Number: 314-13-23
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 04/11/2019
• 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: 59 YR
• Patient Sex: Male