MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SHOULDER COMPONENTS

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

Patient Problem Bacterial Infection (1735)

Event Date 11/19/2020

Event Type  Injury  

Event Description

As reported, a revision due to infection (1st stage) was completed on (b)(6) y/o female patient and a interspace was implanted, no other information is available at this time.Devices were not returned.

Manufacturer Narrative

Section h10: (h3) this case has been determined to be a duplicate.Please see 1038671-2020-00584 for additional details.

• Brand Name: EQUINOXE
• Type of Device: SHOULDER COMPONENTS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10905046
• MDR Text Key: 219145197
• Report Number: 1038671-2020-00629
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR