MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQ REV GLENOID PLATE

Catalog Number 320-15-01

Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to dislocation and loosening.The patient fell and dislocated the shoulder loosening the baseplate.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of the patient's fall, which led to dislocation and glenoid baseplate loosening.

• Brand Name: EQUINOXE
• Type of Device: EQ REV GLENOID PLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8178844
• MDR Text Key: 130794550
• Report Number: 1038671-2018-00965
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 83