MAUDE Adverse Event Report: EQUINOXE; EQ REV COMPRESS SCREW 4.5X42MM

Catalog Number 320-15-42

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Code Available (3191)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision due to dislocation and loosening.

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.

Manufacturer Narrative

Section h10: the following sections have additional info: (d4) catalog number.

• Brand Name: EQUINOXE
• Type of Device: EQ REV COMPRESS SCREW 4.5X42MM
• MDR Report Key: 8311438
• MDR Text Key: 135196781
• Report Number: 1038671-2019-00061
• 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,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-15-42
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 83