MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-29 for HEMICAP TOE IMPLANT manufactured by Arthrosurface.
[5886243]
Arthrosurface hemicap toe implant was placed in my right foot. It has caused more pain and less function than pre op. I have spent hundreds of dollars on f/u appointments and physical therapy that hasn't worked. I am unable to resume my previous active lifestyle and can't perform my job as well. I am scheduled to have this removed and have the toe rebuilt and fused at more expense to me. These implants should be taken off the market. Their success rate is dismal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042492 |
| MDR Report Key | 4749732 |
| Date Received | 2015-04-29 |
| Date of Report | 2015-04-29 |
| Date of Event | 2013-08-08 |
| Date Added to Maude | 2015-05-06 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMICAP TOE IMPLANT |
| Generic Name | HEMICAP TOE IMPLANT |
| Product Code | LZJ |
| Date Received | 2015-04-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-29 |