MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA IMPLANT 10 MM; PROSTHESIS, METATORS OPHALANGEAL JOINT CARTRIDGE REPLACEMENT IMPLANT 10MM

Catalog Number CAR - 10-US 0 - 10MM

Device Problem Malposition of Device (2616)

Patient Problems High Blood Pressure/ Hypertension (1908); Nerve Damage (1979); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 04/06/2017

Event Type  Injury  

Event Description

Had a surgery for hallux rigidus of my big left toe with a cartiva implant put in mtp joint.It was a failed surgery and the implant is not in place.X-rays proved the implant subsided and isn't in the proper place, leaving me with bone on bone.Then i developed crps.The day of the surgery was (b)(6) 2017.I could not accumulate from day one.It was suppose to be easy back to work in 2 weeks.Well, not my story i couldn't walk without crutches - walker, severe pain, redness, swelling.My surgeon stated it was a failed surgery about 7 weeks after, i had retrogressed and still in severe pain.The x-rays confirmed the cartiva implant wasn't in the pacer.It was suppose to be leaving me with bone on bone and the condition chronic regional pain syndrome (crps).This condition leaves me with no option for surgery to correct this issue.The risk is the crps spreading to other parts of my body (nerve damage).The cartiva remains in my foot just not in place.Developed hypertension after surgery, gad, developed crps after the surgery.Ptsd after surgery.

• Brand Name: CARTIVA IMPLANT 10 MM
• Type of Device: PROSTHESIS, METATORS OPHALANGEAL JOINT CARTRIDGE REPLACEMENT IMPLANT 10MM
• Manufacturer (Section D): CARTIVA, INC.
• MDR Report Key: 7037482
• MDR Text Key: 92526434
• Report Number: MW5073385
• Device Sequence Number: 1
• Product Code: PNW
• Combination Product (y/n): N
• 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: 10/20/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: CAR - 10-US 0 - 10MM
• Device Lot Number: F010517002
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 50 YR
• Patient Weight: 64