MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID SMALL, ALPHA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number EQUINOXE CAGE GLENOID SMALL, ALPHA

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 03/07/2024

Event Type  Injury  

Event Description

As reported, the 64 year old female patient had an initial right tsa on (b)(6) 2020.The patient was revised on (b)(6) 2024 due to poly failure.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.No other patient information/medical history reported.Photos & x-rays received.The devices are not available for evaluation due to chain of command.

Manufacturer Narrative

Section d10: concomitant products: - equinoxe, humeral stem primary, press fit 9mm (cat# 300-01-09 / serial# (b)(6)).- equinoxe replicator plate 4.5mm o/s (cat# 00-10-45 / serial# (b)(6)).- equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(6)).- equinoxe, humeral head short, 38mm (alpha) (cat# 310-01-38 / serial# (b)(6)).- equinoxe cage glenoid small, alpha (cat# 314-13-02 / serial# (b)(6)).- glnd kwire (cat# 315-35-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: EQUINOXE CAGE GLENOID SMALL, ALPHA
• Type of Device: PROSTHESIS, SHOULDER, SEMI-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: matt collins
• MDR Report Key: 19038390
• MDR Text Key: 339320084
• Report Number: 1038671-2024-00734
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10885862172679
• UDI-Public: 10885862172679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2024
• Device Model Number: EQUINOXE CAGE GLENOID SMALL, ALPHA
• Device Catalogue Number: 314-13-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2019
• 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: GPS IMPLANT KIT V2; SHOULDR GPS HEX PINS KIT
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female