MAUDE Adverse Event Report: CARTIVA CARTIVA JOINT IMPLANT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); Joint Dislocation (2374)

Event Date 01/31/2017

Event Type  Injury  

Event Description

Dislodgement of cartiva implant to the first metatarsal joint.

• Brand Name: CARTIVA JOINT IMPLANT
• Type of Device: CARTIVA JOINT IMPLANT
• Manufacturer (Section D): CARTIVA
• MDR Report Key: 6597579
• MDR Text Key: 76263332
• Report Number: MW5070048
• Device Sequence Number: 1
• Product Code: PNW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/25/2017

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: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 150