MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	300-01-13
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Aseptic loosening (4883)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 6 years post op the initial left tsa, this 79 y/o male patient was revised due to stem loosening.Patient's humeral components and glenosphere were removed and exchanged due to the stem being loose.Patient was revised to a long stem 10 x 200mm.Patient was last known to be in stable condition following the event.Devices are not returning, hospital policy.
Additional Manufacturer Narrative
Concomitant device(s): 2608995, 320-01-42 - equinoxe reverse 42mm glenosphere, 2691154, 320-10-00 - equinoxe reverse tray adapter plate tray +0, 2679911, 320-15-01 - eq rev glenoid plate, 2384691, 320-15-05 - eq rev locking screw, 2705146, 320-20-00 - eq reverse torque defining screw kit, 2585764, 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, 2664313, 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, 2686704, 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, 2686915, 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, 2513008, 320-42-03 - equinoxe reverse 42mm humeral liner +2.5, 2683515, 321-20-00 - equinoxe reverse shoulder drill kit.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was most likely the result of aseptic loosening of the humeral stem after 9 years of implantation.However, this cannot be confirmed as the devices were not available for evaluation and possible contributions from patient-related conditions to the loosening cannot be determined due to limited clinical information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d6a, d8, g1, h6 - health effect - clinical code, investigation findings, investigation conclusions and h11.The revision reported was most likely the result of aseptic loosening of the humeral stem after 9 years of implantation.However, this cannot be confirmed as the devices were not available for evaluation and possible contributions from patient-related conditions to the loosening cannot be determined due to limited clinical information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM
• 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 court; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 15708086
• Report Number: 1038671-2022-01381
• Device Sequence Number: 4972263
• Product Code: KWT
• UDI-Device Identifier: 10885862079329
• UDI-Public: 10885862079329
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 03/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: 300-01-13
• Device Catalogue Number: 300-01-13
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 03/23/2023; 03/24/2026
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 04/14/2023; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2013
• 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: 79 YR
• Patient Sex: Male