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

Catalog Number	314-13-02
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, the 48 year old female patient had an initial left tsa on (b)(6) 2013 and presented with breakage - component, 10 year(s) and 6 month(s) post initial procedure on (b)(6) 2024.Broken screws at the glenoid baseplate interface.The case report form indicates that this event is definitiely related to the device and/or to the procedure.The report also indicates that the action taken was revision on (b)(6)2024 with the removal of the following components: standard humeral stem, replicator plate, torque screw, humeral head, glenoid.The outcome is reported as resolved.No device return anticipated due to being a clinical trial study.
Additional Manufacturer Narrative
(h3) pending evaluation: (d10) concomitant device(s): (b)(6), 300-01-09 - equinoxe, humeral stem primary, press fit 9mm; (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s; (b)(6), 310-01-44 - equinoxe, humeral head short, 44mm (alpha); (b)(6), 314-13-02 - equinoxe cage glenoid small, alpha.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information the following sections were corrected: b2, b5, d1, d4, d10, g1, g2, g4, h4, h6 - health effect - clinical code, medical device problem code, component code, type of investigation, investigation findings and investigation conclusions 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
It was reported that the patient underwent an initial left tsa approximately 12 years and 2 months ago.Subsequently, it was reported that the "screws" at the glenoid-bone interface broke.As a result, the patient underwent a left shoulder revision approximately 10 years and 8 months after initial implantation.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6 mdr section codes updated/corrected: a, b, c, d the cause of the breakage reported could not be determined and the event could not be confirmed because the component was not returned for evaluation and no images or radiographs were provided.Additionally, the glenoid components for anatomic shoulder components do not utilize screws, and the reporter may have meant that the peripheral pegs and/or center cage of the anatomic glenoid may have fractured from the body.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 SMALL, ALPHA
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18724351
• Report Number: 1038671-2024-00247
• Device Sequence Number: 12339994
• Product Code: KWS
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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: 05/01/2017
• Device Catalogue Number: 314-13-02
• 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: 01/17/2024
• Supplement Date Received by Manufacturer: 07/17/2025; 09/12/2025
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 07/17/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2012
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: Black Or African American