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

Catalog Number	314-02-02
Medical Device Problem Codes	Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Loss of Range of Motion (2032)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 8 year(s), 11 month(s) and 16 day(s) post-operative of a left tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening.Patient continued to experience pain and decreased rom.Ct scan demonstrated loosening behind the glenoid component with some cystic changes behind the glenoid.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/or to the procedure.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-01-11 - equinoxe, humeral stem primary, press fit 11mm: 1335778.300-10-15 - equinoxe replicator plate 1.5mm o/s: 1539921.300-20-02 - equinox square torque define screw drive kit: 1600508.310-01-41 - equinoxe, humeral head short, 41mm (alpha): 1471035.1400-a - cemex 40g rx kit: aa1691.
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 an insufficient bond between the glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.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 GLENOID, PEGGED ALPHA, SMALL
• 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: 20191795
• Report Number: 1038671-2024-03452
• Device Sequence Number: 7058378
• Product Code: KWS
• UDI-Device Identifier: 10885862084477
• UDI-Public: 10885862084477
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2010
• Device Catalogue Number: 314-02-02
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2005
• 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.
• Patient Sex: Unknown