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

Catalog Number	320-31-36
Medical Device Problem Codes	Unintended Collision (1429); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: a10012 - gps implant kit v2 (b)(6).320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm (b)(6).531-78-20 - shouldr gps hex pins kit (b)(6).300-01-09 - equinoxe, humeral stem primary, press fit 9mm (b)(6).315-35-00 - glnd kwire 6748768.320-10-00 - equinoxe reverse tray adapter plate tray +0 (b)(6).320-20-00 - eq reverse torque defining screw kit (b)(6).531-20-00 - shldr gps rvrs drill kit (b)(6).320-35-01 - small glenoid plate (b)(6).320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6).
Event or Problem Description
It was reported that a 58 yo patient, initial right shoulder implanted in (b)(6) 2021, underwent a revision procedure in (b)(6) 2024, approximately 3 years 8 months post the initial procedure.The patient presented with humeral pain.A ct revealed some impingement on the inferior glenoid.The surgeon removed glenoid and following trialing, implanted a 36 expanded glenoid.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were available.The explanted devices are not available for return.They were discarded.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h3 - the revision reported was likely the result of joint impingement leading to prosthesis wear of the humeral liner and pain.The reason for the impingement cannot be determined from the reported information, but may be related to implant positioning, implant size, and/or patient anatomy.However, this cannot be confirmed because the components were not returned for evaluation and no radiographs were provided.H6 - device problem, component, inv type, inv findings, inv conclusion codes the following sections were corrected: d4 - catalog #, exp date, serial #, udi # no longer applies g4 - 510k# no longer applies h4 - mfg date no longer applies h6 - codes 1429, 4756, 4118, 3233, 11 no longer applies should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE
• 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21029967
• Report Number: 1038671-2024-05035
• Device Sequence Number: 9180863
• Product Code: KWT
• UDI-Device Identifier: 10885862534934
• UDI-Public: 10885862534934
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Catalogue Number: 320-31-36
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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: 58 YR
• Patient Sex: Female