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

Catalog Number	314-13-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Muscle/Tendon Damage (4532); Implant Pain (4561)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, the patient had an initial left tsa on 05-sep-2017 and presented on 20-apr-2018 with aseptic glenoid loosening.Patient begin lifting heavy weights in the gym.Had unexplained shoulder pain and signs of subscapularis tear.The case report form indicates that this event is possibly related to device and/ to procedure.Outcome is resolved by revision (b)(6) 2018.No device return anticipated due to being a clinical trial study.Ebi initial surgery attached.
Additional Manufacturer Narrative
(h3) pending evaluation (d10) concomitant device(s): 300-30-08 - equinoxe preserve stem 8mm: 4949004 310-00-53 - equinoxe, hum head, extra short, 53mm: 4622236 300-50-45 - 4.5mm short rep plate: 4895064.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reported shoulder pain may be the result of glenoid loosening due to eccentric loading of the glenoid secondary to instability resulting from the reported rotator cuff tear.Additionally, patient young age at implant and increased activity level could be contributing factors.However, the failure and potential contributions from manufacturing, patient, or user-related issues to the event cannot be confirmed as the devices were not returned for evaluation and no images or radiographs were 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, BETA
• 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
• Manufacturer Contact: miguel sosa ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18465255
• Report Number: 1038671-2024-00032
• Device Sequence Number: 3166909
• Product Code: KWS
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 07/12/2022
• Device Catalogue Number: 314-13-13
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2017
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 44 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: White