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

Catalog Number 320-01-38

Device Problem No Apparent Adverse Event (3189)

Patient Problem Unspecified Infection (1930)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

D10.Concomitants: humeral stem or stemless 3000111.Reverse humeral liner 3203800.Reverse humeral tray 3201000.Reverse glenosphere baseplate 3201502.

Event Description

It was reported post-op via clinical study that the 78 yo female patient was suspected to have an infection with increased pain and raised inflam markers.However, more recent blood tests, and no progression on x-ray, suggests no infection.There was no action taken.Will continue to watch.The date of event onset is (b)(6) 2021.The outcome was last known as continuing.

• 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: 17451930
• MDR Text Key: 320318853
• Report Number: 1038671-2023-01805
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063569
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-38
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White