MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REPLICATOR PLATE 4.5MM O/S; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number 300-10-45

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

Patient Problem Failure of Implant (1924)

Event Date 11/02/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the shoulder revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.It is known that patient¿s age, weight, and activity level, would cause the surgeon to expect early failure of the system.Concomitant medical products: 300-20-02 - equinox square torque define screw drive kit 6912735, 310-03-47 - equinoxe, humeral head expanded, 47mm (beta) 4184470.

Event Description

As reported, approximately 9 months post op the right reverse total shoulder arthroplasty of this 69 y/o male patient was revised.The patient presented with glenoid erosion from a hemi in place and was revised to exactech reverse humeral components and other manufactures glenoid components.There were no reported issues with the revision procedure.The patient was deemed stable after the procedure.The devises will not be returned due to hospital policy.No additional information.

• Brand Name: EQUINOXE REPLICATOR PLATE 4.5MM O/S
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 16016670
• MDR Text Key: 305834769
• Report Number: 1038671-2022-01610
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042021
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: 300-10-45
• Device Catalogue Number: 300-10-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male