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

Model Number EQUINOXE REVERSE 42MM GLENOSPHERE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 02/15/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant products: eq rev locking screw (cat# 320-15-05 / serial# (b)(4)); equinoxe, humeral stem primary, press fit 13mm (cat# 300-01-13 / serial# (b)(4)); equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(4)); eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(4)); equinoxe reverse 42mm humeral liner +0 (cat# 320-42-00 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately one months post initial right tsa, the 59 y/o male patient had a revision due to dislocation.Patient was too active after surgery.Patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays/photos.The devices are not available for evaluation as they were disposed by hospital.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported, approximately one months post initial right tsa, the 59 y/o male patient had a revision due to dislocation.Patient was too active after surgery.Patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain x-rays/photos.The devices are not available for evaluation as they were disposed by hospital.Additional information received indicates that there is no implant x-rays and any pre-revision x-rays for this revision or any additional information other than what was provided in the report.Based on review of all available information, there is no evidence to suggest that the reported dislocation and revision are related to any design, manufacturing, or patient related issues.The cause of the revision is most likely is related to the patient¿s underlying condition; however, that could not be confirmed.

• Brand Name: EQUINOXE REVERSE 42MM GLENOSPHERE
• Type of Device: 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16700816
• MDR Text Key: 312875610
• Report Number: 1038671-2023-00612
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (2); EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; EQ REV GLENOID PLATE; EQUINOXE REVERSE SHOULDER DRILL KIT; GLND KWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male