MAUDE Adverse Event Report: CARTIVA, INC. CARTIVA; PROSTHESIS, TOE, HEMI-, PHALANGEAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)

Event Date 02/02/2016

Event Type  Injury  

Event Description

Caller reported having pain without fracture in toe joint for 2 years prior to cartiva implant.Consulted a surgeon who encouraged her to have device implanted (b)(6) 2019.After surgery pain continued and worsened, expressed difficulty ambulating.Caller contacted internist and x-ray showed bone on bone, bone spurs returned, and fracture in foot.Internist shared that his colleague wrote a paper on the negative effects of cartiva.Caller stated her symptoms aligned with others who have had adverse effects post implant surgery.On (b)(6) 2019 cartiva was removed and bone was fused.Caller expressed she was living in hell for 2 years post surgery, tried pt, 2 podiatrists and several other interventions prior to removal.

• Brand Name: CARTIVA
• Type of Device: PROSTHESIS, TOE, HEMI-, PHALANGEAL
• Manufacturer (Section D): CARTIVA, INC.
• MDR Report Key: 8772788
• MDR Text Key: 150606540
• Report Number: MW5087964
• Device Sequence Number: 0
• Product Code: KWD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/08/2019

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR