MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET

Catalog Number 320-02-42

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index (b)(6) 2017.Revision due to instability.

Manufacturer Narrative

The revision reported was likely the result of instability due to ligament issues.However, this cannot be confirmed as the devices were not available for evaluation and no further information was provided."soft tissue damage which may lead to a second surgical intervention or revision" is listed in the total joint surgery risk of the equinoxe shoulder system ifu 700-096-060.

• Brand Name: EQUINOXE
• Type of Device: RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8332925
• MDR Text Key: 135989378
• Report Number: 1038671-2019-00083
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-02-42
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR