MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-02-42
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Concomitants: 308-05-23 - distal fixation ring ha 23.5 (b)(6) 308-01-08 - 8x80mm distal stem modular cemented (b)(6) 308-12-00 - med prox body +12.5 (b)(6) 320-42-10 - equinoxe reverse 42mm humeral const liner +0 (b)(6) 308-16-12 - taper locking screw 112 (b)(6) 308-10-25 - 25mm middle segment modular (b)(6) 308-10-75 - 75mm middle segment modular (b)(6) 320-10-05 - equinoxe reverse tray adapter plate tray +5 (b)(6) 320-15-05 - eq rev locking screw (b)(6) 320-20-00 - eq reverse torque defining screw kit (b)(6).
Event or Problem Description
As reported, approximately 28 weeks post initial left reverse total shoulder arthroplasty (tsa), the shoulder dislocated while the patient was on holidays and as a result became infected.A revision was performed at which time the surgeon put a larger glenosphere and performed a wash out.The event was not related to the breakage of a device and did not lead to a surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
"this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6.The following sections were corrected: b2, d1, d4, g2, g4, h6.A review of the sterile certificates and the final endotoxin test reports was performed.All lots were accepted to the requirements.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.A relationship between the reported infection and dislocation could not be confirmed or established.The cause of the patient¿s dislocation may be related to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.However, this cannot be confirmed because the devices were not returned for evaluation, and clinical information, device images, or radiographs were not provided.Dislocation and infection are known risks, as outlined in the ifu.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.".

• Brand Name: EQUINOXE RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20799371
• Report Number: 1038671-2024-04541
• Device Sequence Number: 20556657
• Product Code: KWT
• UDI-Device Identifier: 10885862186768
• UDI-Public: 10885862186768
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-02-42
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 90 KG