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

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to dislocation.

Manufacturer Narrative

The revision reported was likely due to dislocation.A review of the dhr and/or the sterilization records was not conducted because the event as described is a clinical event that does not appear to be related to the design, manufacturing, or reasonably foreseeable misuse of the device.A review of the equinoxe shoulder system ifu 700-096-060 rev m was conducted.Device specific risks include fracture, migration, loosening, subluxation, or dislocation of the prothesis or any of its components, any of which may require a second surgical intervention or revision.

• Brand Name: EQUINOXE
• Type of Device: SHOULDER COMPONENTS
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8768297
• MDR Text Key: 150289629
• Report Number: 1038671-2019-00363
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR