MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRIMARY SHOULDER COMPONENT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	320-31-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-30-09 - equinoxe preserve stem 9mm 6938075, 320-10-00 - equinoxe reverse tray adapter plate tray +0 6992287, 320-15-05 - eq rev locking screw 7003748, 320-20-00 - eq reverse torque defining screw kit 6954164, 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm s290132, 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm s267510, s268670, 320-35-07 - small superior/posterior aug glenoid plate,left 6149568, 320-40-00 - humeral liner, 40mm, +0 6196798, 531-20-00 - shldr gps rvrs drill kit 6610764, 531-78-20 - shouldr gps hex pins kit 6825489, a10012 - gps implant kit v2 04078521047.
Event or Problem Description
As reported, approximately 1year post op the initial left tsa, this 71 y/o female patient was revised due to shoulder feeling like it was loose.Patient reported shoulder feeling like it was loose.Revised and deemed to be stable.
Event or Problem Description
As reported, approximately 1 year post op the initial left tsa, this 71 y/o female patient was revised due to stating shoulder feeling like it was loose.There were no reported issued during the surgical revision.The patient was revised and deemed to be stable.The device was not returned due to hospital policy.New information on 27 sep 2022: the patient had joint laxity.No components were loose.No additional information.
Additional Manufacturer Narrative
Section h10: h3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the shoulder instability and revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, approximately 1year post op the initial left tsa, this 71 y/o female patient was revised due to stating shoulder feeling like it was loose.There were no reported issued during the surgical revision.The patient was revised and deemed to be stable.The device was not returned due to hospital policy.New information on 27 sep 2022: the patient had joint laxity.No components were loose.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: d1, d4 (remove all from initial report-suspect device unknown), d8, g4 (remove from initial report-501k unknown), h6: clinical code, investigation findings and investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE PRIMARY SHOULDER COMPONENT
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15546312
• Report Number: 1038671-2022-01251
• Device Sequence Number: 5684640
• Product Code: KWT
• UDI-Device Identifier: 10885862534972
• UDI-Public: 10885862534972
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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 Model Number: 320-31-40
• Device Catalogue Number: 320-31-40
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 10/14/2025
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/08/2022; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2020
• 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 H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female