MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-02 for CARTIVA IMPLANTS manufactured by Wright Medical Technology, Inc..
[153416428]
I had a cartiva implant (made by wright medical) surgically inserted into my right big toe on (b)(6) 2018. It was touted to be an effective treatment for halux-rigidus - basically arthritis of the big toe. Since the surgery was performed, the pain has only gotten worse. I can barely walk without extreme discomfort in most shoes. A subsequent mri has revealed that the implant has created (in the surgeon's words) a stress reaction in the bone. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5088751 |
| MDR Report Key | 8861270 |
| Date Received | 2019-08-02 |
| Date of Report | 2019-07-31 |
| Date of Event | 2018-11-01 |
| Date Added to Maude | 2019-08-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 IMPLANTS |
| Generic Name | PROSTHESIS, TOE, HEMI |
| Product Code | KWD |
| Date Received | 2019-08-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Brand Name | CARTIVA IMPLANTS |
| Generic Name | PROSTHESIS, TOE, HEMI |
| Product Code | KWD |
| Date Received | 2019-08-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT TECHNOLOGY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-02 |