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	Pain (1994)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant device(s): 310-61-44 - stemless humeral head 44mm x 17mm x alpha: 5457506 310-61-44 - stemless humeral head 44mm x 17mm x alpha: 5457506 300-62-02 - stemless humeral comp integrip, cage, size 2: 5483858 319-01-32 - steinmann pin sterile 3.2mm x 178mm: 5676029 a10012 - gps implant kit v2: 12008018008.
Event or Problem Description
It was reported that approximately 63 months after a total shoulder replacement procedure, a patient has experienced pain and aseptic glenoid loosening.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
After review of additional information received the following sections b2, b5, d6b, g1, g3, g6, h1, h2, and h6 have been updated accordingly.
Event or Problem Description
Approximately 5 year(s), 7 month(s) and 17 day(s) post-operative of a right rtsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.The patient noticed increased pain after pitching a significant number of baseball games.The patient was administered subacromial injection for persistent symptoms and underwent a standard total with stemless revision with the reported removal of the glenoid, stemless humeral head, and stemless humeral cage.The outcome of this event is now considered resolved and the clinical report indicates that this event is definitely related to the device(s) and/or to the procedure.This was reported through clinical trial study data collection activities and no other information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision reported cannot be confirmed from the information provided but may be the result of the stresses on the joint related to the patient's reported activity and/or of an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.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 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19591797
• Report Number: 1038671-2024-02071
• Device Sequence Number: 8470224
• Product Code: KWS
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2025

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: 08/28/2023
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 02/18/2025
• Initial Report FDA Received Date: 06/23/2024
• Supplement Report FDA Received Date: 11/11/2024; 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: Black Or African American