MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for CARTIVA SYNTHETIC IMPLANT manufactured by Wright Medical Group / Cartiva, Inc..
[184179156]
I had cartiva synthetic implant (csi) surgery on my right big toe for hallux rigidus. The surgery was done by dr (b)(6) of (b)(6), at (b)(6) outpatient surgery center. The surgeon was a failed csi surgery and after 1 1/2 years more of bad pain. I had corrective surgery on (b)(6) 2020 (removal of implant, bone grafts and fusion of big toe) by dr (b)(6) of (b)(6). I had to remain in hosp for 2 nights after the corrective surgery due to complications unrelated to the surgery. I suffered vocal cord abrasion due to anesthesiologist insertion of air tube. I want to report the failed cartiva implant surgery so the fda is properly notified as i do not know if dr (b)(6) reported it as failed. The implant had completely receded into the hole as the implant hole was to deep. When i first read the fda studies on csi it showed a very low (single digit) failure rate but in the real world that failure rate is well over (b)(4)%, why? ; dr (b)(6), (b)(6); cat/lot/ serial number/ udi: ask dr (b)(6). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093802 |
| MDR Report Key | 9847735 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-14 |
| Date of Event | 2018-02-13 |
| Date Added to Maude | 2020-03-18 |
| 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 | CARTIVA SYNTHETIC IMPLANT |
| Generic Name | PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT |
| Product Code | PNW |
| Date Received | 2020-03-17 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL GROUP / CARTIVA, INC. |
| Brand Name | TUBE, TRACHEAL (W/WO CONNECTOR) |
| Generic Name | TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | PNW |
| Date Received | 2020-03-17 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-17 |