MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for CARTIVA IMPLANT manufactured by Wright Medical Group / Cartiva Inc..
[145990122]
On (b)(6) 2017 received a cartiva implant left great toe. It failed almost immediately. I lost the ability to move my toe, increased pain, constant anguish. A few weeks after receiving a cartiva implant, a physical therapist said my toe was fused and physical therapy wouldn't help. I now have bone on bone pain. My pain, ability to move my toe joint, my mobility and my quality of life are significantly worse after getting cartiva. I'm miserable. Based on my research, there is a discrepancy in cartiva's clinical study data (glowing, amazing reviews) and the amount of cartiva complaints after being fda approved. This product should be taken off the market. I'd like to file a formal complaint about the cartiva implant. Https://www. Cartiva. Net/home/about; more pain, less mobility. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086828 |
| MDR Report Key | 8632306 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-19 |
| Date of Event | 2017-09-11 |
| Date Added to Maude | 2019-05-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARTIVA IMPLANT |
| Generic Name | PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT |
| Product Code | PNW |
| Date Received | 2019-05-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL GROUP / CARTIVA INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-21 |