MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; +0 POLY LINER

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

Patient Problem Joint Dislocation (2374)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

Pending evaluation concomitant medical products: 38mm glenosphere, glenosphere locking screw.No information provided in the following section(s).

Event Description

As reported, approximately 6 years after this this 85 y/o male patient had a left tsa, his humerus dislocated from the glenosphere.The doctor was able to go in and put the shoulder back in place.Removing the 38mm glenosphere and putting in a +4 lateralized glenosphere instead.As well as putting in a +2.5 constrained poly liner.After taking out a +0 liner.The patient is in post-operative recovering and hopefully discharged in the next few days.Devices were disposed of by the facility.

Manufacturer Narrative

Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Type of Device: +0 POLY LINER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10670419
• MDR Text Key: 216393256
• Report Number: 1038671-2020-00569
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• 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: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR