MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-08 for SWANSON TRAPEZIUM IMPLANT manufactured by Wright Medical Technology, Inc..
[99875454]
Patient had the trapezium implanted in his right wrist 15 years ago. Patient reported he was not told the implant was made of silicon. Patient complaining of pain and implant is eating his right arm away. Patient stated it is getting hard for him to use the right hand as he is right handed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075136 |
| MDR Report Key | 7259303 |
| Date Received | 2018-02-08 |
| Date of Report | 2018-02-08 |
| Date of Event | 2003-01-01 |
| Date Added to Maude | 2018-02-09 |
| 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 | SWANSON TRAPEZIUM IMPLANT |
| Generic Name | PROSTHESIS, WRIST, CARPAL TRAPEZIUM |
| Product Code | KYI |
| Date Received | 2018-02-08 |
| Device Availability | * |
| 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 | 1. Other | 2018-02-08 |