MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 42MM GLENOSPHERE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 42MM GLENOSPHERE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant devices.Eq rev locking screw (cat# 320-15-05 / serial# (b)(6)).Eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)) equinoxe reverse 42mm humeral liner +2.5 (cat# 320-42-03 / serial# (b)(6)) equinoxe preserve stem 7mm (cat# 300-30-07 / serial# (b)(6)) equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported approximately 14 days after left total shoulder revision, the patient was revised due to dislocation.The humeral stem, tray, liner, and glenosphere were revised.The event was not related to a breakage of the device.The event did not lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain images or x-rays.The devices are not available for evaluation as they were discarded by the hospital.
Additional Manufacturer Narrative
Additional information h3: the cause of the patient¿s shoulder dislocation and subsequent revision cannot be conclusively determined; however, it may be due to a soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.However, this cannot be confirmed as the devices were not returned for evaluation, and images or radiographs were not provided.Dislocation is a known risk, as stated in the ifu.H6: component code, investigation codes.

• Brand Name: EQUINOXE REVERSE 42MM GLENOSPHERE
• 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
• MDR Report Key: 19657270
• Report Number: 1038671-2024-02269
• Device Sequence Number: 6483941
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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 Model Number: EQUINOXE REVERSE 42MM GLENOSPHERE
• Device Catalogue Number: 320-01-42
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• 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: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM.; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM.; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM.; EQ REV GLENOID PLATE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male