MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	300-01-11
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: a966201 - 320-01-38 - equinoxe reverse 38mm glenosphere.A998298- 320-10-00 - equinoxe reverse tray adapter plate tray +0.A744140- 320-15-01 - eq rev glenoid plate.A960792 -320-15-05 - eq rev locking screw.A950920 -320-20-00 - eq reverse torque defining screw kit.A824269- 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm.A693600- 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.A784432- 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.S505139- 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.A969263 -320-38-00 - equinoxe reverse 38mm humeral liner +0 a886348- 531-78-20 - shouldr gps hex pins kit.11054823170- a10012 - gps implant kit v2.
Event or Problem Description
As reported, approximately 2 months post an initial right tsa, the stem rotated inside the canal and the patient dislocated their shoulder.The patient was revised and everything was removed.The surgeon decided to cement in a stem and do a higher glenosphere.There was no reported breakage of a device or 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 d6b d8 h6.The revision reported was likely the result of humeral loosening possibly leading to stem migration and joint dislocation.However, this cannot be confirmed and potential contributions from patient or user related considerations to the event could not be assessed because the components were not returned for evaluation, and no images, radiographs, or relevant clinical information was 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, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• 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: 20175941
• Report Number: 1038671-2024-03387
• Device Sequence Number: 8851086
• Product Code: HSD
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 300-01-11
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2023
• 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 Sex: Female