MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-02 for CARTIVA IMPLANT manufactured by Wright Medical Technology, Inc..
[153842932]
Received a cartiva joint replacement implant in my left big toe to help resolve hallux rigidus. In more than a year post-surgery, my pain has increased to levels worse than it was before surgery. Received a second opinion from another surgeon who stated that the joint space has decreased significantly and she recommends removing the cartiva implant and replacing it with a hemicap implant. She mentioned she sees a lot of failed cartiva implants. Surgery to remove cartiva and replace it with hemicap scheduled for (b)(6) 2019. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5088752 |
MDR Report Key | 8861289 |
Date Received | 2019-08-02 |
Date of Report | 2019-07-31 |
Date of Event | 2018-05-03 |
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 | 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, TOE, HEMI |
Product Code | KWD |
Date Received | 2019-08-02 |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-08-02 |