MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-31 for CARTIVA IMPLANTS manufactured by Cartiva, Inc..
[153498944]
On (b)(6) 2017, i had bilateral toe surgery to place cartiva implants in my great toes due to severe hallux rigidus. The surgery was performed by dr (b)(6) in (b)(6). I diligently went through physical therapy. I followed-up with dr (b)(6) on two separate occasions in 2018 due to pain in my toes, lack of balance and rigidity in my toes. Each time, i had x-rays and was told that i was still swollen and healing. " on (b)(6) 2019 i returned to dr (b)(6) for my one year f/u. I had repeat x-rays and was told that both cartiva implants had failed. They had receded and both toe joints are "bone-on-bone. " dr (b)(6) informed me at this appt that he no longer performs the cartiva implant surgery due to its high failure rate, which he claimed is around 50% and not the 90% success rate claimed by the cartiva company. Both x-rays revealed the cartiva implants had recessed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5088686 |
| MDR Report Key | 8856813 |
| Date Received | 2019-07-31 |
| Date of Report | 2019-07-29 |
| Date of Event | 2017-12-08 |
| Date Added to Maude | 2019-08-02 |
| 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 IMPLANTS |
| Generic Name | PROSTHESIS, TOE, HEMI |
| Product Code | KWD |
| Date Received | 2019-07-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARTIVA, INC. |
| Brand Name | CARTIVA IMPLANTS |
| Generic Name | PROSTHESIS, TOE, HEMI |
| Product Code | KWD |
| Date Received | 2019-07-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CARTIVA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-07-31 |