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

Model Number 320-01-38

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 01/22/2023

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: 300-01-13 - equinoxe, humeral stem primary, press fit 13mm; 320-38-00 - equinoxe reverse 38mm humeral liner +0; 320-10-00 - equinoxe reverse tray adapter plate tray +0; 320-15-03 - rs glenoid plate l post aug, 8 deg, left.

Event Description

It was reported via clinical study that the 80 yo male experience dislocation (reduced at hospital).The date of event onset is (b)(6) 2023.The patient was treated with immobilization in a sling for 3 weeks and gentle rehabilitation after immobilization.The next review is may 2023.The outcome was last known as resolved on (b)(6) 2023.

Manufacturer Narrative

Section h10: (h3) 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
• 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 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17102544
• MDR Text Key: 316935007
• Report Number: 1038671-2023-01310
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 320-01-38
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/11/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SEE H10
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 69 KG