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

Model Number	EQUINOXE CAGE GLENOID L, POST AUG, RIGHT
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); Joint Laxity (4526)
Date of Event	08/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a male patient, initial right shoulder implanted on (b)(6) 2020, underwent a stage 1 revision procedure on (b)(6) 2023, approximately 3 years post the initial procedure.The patient was revised due to post-traumatic instability which was developed due to a rupture of the pcr.After opening the shoulder, the poly was found disassociated from the pegs of the cage glenoid.Everything was removed and a cement spacer was inserted.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No device images or x-rays were available.The devices are not available for return as the hospital disposed of them.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 300-10-15, equinoxe replicator plate 1.5mm o/s.(b)(6), 300-20-02, equinox square torque define screw drive kit.(b)(6), 300-30-11, equinoxe preserve stem 11mm.(b)(6), 310-01-47, equinoxe, humeral head short, 47mm (beta).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H3: upon review of the available information, there is no evidence that this is a device related problem and there is no allegation against the device.Implantation of a total joint could result pain, infection, or instability of total joint hardware.The most likely cause of the reported event is the patient¿s activity and the surgeon¿s choice of initial implant.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d1, d4, g4, h4: suspect device unknown, h6: clinical code, impact code, medical device problem code, component code, type of investigation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE PRIMARY SHOULDER 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17634266
• Report Number: 1038671-2023-02065
• Device Sequence Number: 15071229
• Product Code: KWS
• Combination Product (Y/N): N
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/08/2026

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: 09/17/2023
• Device Model Number: EQUINOXE CAGE GLENOID L, POST AUG, RIGHT
• Device Catalogue Number: 314-13-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 10/24/2025; 09/04/2026
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 12/13/2023; 10/24/2025; 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2018
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male