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

Catalog Number	314-13-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.Concomitants: (b)(6) 300-01-11 - equinoxe, humeral stem primary, press fit 11mm (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).310-01-44 - equinoxe, humeral head short, 44mm (alpha).
Event or Problem Description
As reported, approximately 9 years and 3 months post the initial total shoulder arthroplasty, the glenoid component became loose and the patient was revised to reverse components.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
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3/g4, h6.The following sections were corrected: h6.Mdr section codes updated/corrected: b, c, d.The reason for the revision reported cannot be confirmed from the information provided but may be the result of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) anatomic glenoid loosening.An additional contributing factor may have been inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.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 MEDIUM, 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20450390
• Report Number: 1038671-2024-03978
• Device Sequence Number: 15254843
• Product Code: KWS
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 01/31/2025

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: 04/04/2020
• Device Catalogue Number: 314-13-03
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 01/31/2025
• Date Device Manufactured: 04/07/2015
• 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: 78 YR
• Patient Sex: Male