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 Codes	Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Inadequate Osseointegration (2646)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Approximately 6 year(s), 10 month(s) and 10 day(s) post-operative of a right tsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening and polyethylene wear with or without osteolysis.Patient reported increased pain and reported falls.The patient will be monitored every 6 months for changes.Patient elected to not pursue further work up and possible revision at this time.The outcome of this event is considered continuing, and the case report form indicates that this event is possibly related to the device(s) and unlikely related to the procedure.This was reported through clinical trial study data collection activities, no device return is anticipated, and no other information is available at this time.
Additional Manufacturer Narrative
(d10) concomitant devices: 300-30-10 - equinoxe preserve stem 10mm: 5136677; 310-02-47 - equinoxe, humeral head tall, 47mm (beta): 4368897; 300-10-45 - equinoxe replicator plate 4.5mm o/s: 4879211.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.
Additional Manufacturer Narrative
The pain reported may be the result of the glenoid loosening and prosthesis wear as reported.However, the glenoid loosening and prosthesis wear cannot be confirmed and the underlying reason and/or any contributing factors to the event cannot be confirmed as the devices remain implanted and no radiographs were provided.H6: corrected health effect, component, and investigation clinical codes.

• 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
• MDR Report Key: 21324123
• Report Number: 1038671-2025-00701
• Device Sequence Number: 7865622
• Product Code: KWS
• UDI-Device Identifier: 10885862201010
• UDI-Public: 10885862201010
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 02/27/2022
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 03/01/2017
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White