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

Catalog Number 320-01-36

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: 320-36-00 reverse humeral liner 320-10-05 reverse humeral tray 320-36-00 humeral liner +0 unconstrained 36mm.

Event Description

It was reported via clinical study that the 76 yo female patient experienced an anterior dislocation caused by deep joint infection.There was no injury moi reported.The date of event onset is (b)(6) 2023.The patient was revised on (b)(6) 2023.Additional patient treatment involved, rtsa hardware removal and placement of antibiotic spacer.The outcome was last known as resolved.

• 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: 17233675
• MDR Text Key: 318173809
• Report Number: 1038671-2023-01510
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862086372
• UDI-Public: 10885862086372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093275
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-01-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: White