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

Catalog Number	314-13-33
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 300-62-02 - stemless humeral comp integrip, cage, size 2: (b)(6).310-60-53 - stemless humeral head extra short, 53mm (beta): (b)(6).
Event or Problem Description
Approximately 5 year(s), 7 month(s) and 15 day(s) post-operative of a right tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.Patient presented with glenoid loosening, disassociation of poly.The patient underwent a standard total revision, and the outcome of this event is considered resolved.The clinical report indicates that this event is possibly related to the device(s) and definitely not related to the procedure.
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: a, b, c, d, g.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) glenoid loosening and/or disassembly.Potential contributions of user-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 M, 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: 20076335
• Report Number: 1038671-2024-03111
• Device Sequence Number: 15079995
• Product Code: KWS
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: 07/25/2023
• Device Catalogue Number: 314-13-33
• 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: 08/16/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 02/14/2025
• Date Device Manufactured: 07/27/2018
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White