MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for CARTIVIA IMPLANT manufactured by Wright Medical / Cartiva, Inc..
[183347716]
I had the cartiva implant on my right big (1st) toe to help with extreme pain and arthritis in that toe. I went to dr (b)(6) with (b)(6) orthopedics. After evaluating my toe, he said i have arthritis on the 1st mtp joint, 1st proximal phalanx dorsal bone spur. Dr (b)(6) recommended surgery - right hallux cheilectomy and cartiva implant insertion. I had this surgery on (b)(6) 2018. Since this surgery, i have experienced more pain from my big toe than i had prior to surgery. I have no range of motion after months of physical therapy on the toe, use of a dynasplint on the toe and several f/u visits with dr (b)(6). The cartiva implant has caused me to walk with a limp, and i did not have a normal quality of life because of this surgery and implant. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093656 |
| MDR Report Key | 9818042 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-08 |
| Date of Event | 2018-05-21 |
| Date Added to Maude | 2020-03-11 |
| 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 | 3 |
| Brand Name | CARTIVIA IMPLANT |
| Generic Name | PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT |
| Product Code | PNW |
| Date Received | 2020-03-10 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL / CARTIVA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |