N
Patient 1
NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
MAUDE MDR 8200964
- MDR report key
- 8200964
- Report number
- 1043534-2018-00215
- Event key
- 0
- Event type
- 3
- Date received
- 2018-12-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR MATTHEW PARRISH
- Address
- 1023 CHERRY RD MEMPHIS TN 38117 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SWANSON FINGER JOINT | PROSTHESIS, FINGER, POLYMER | WRIGHT MEDICAL TECHNOLOGY, INC. | KWF | UNK | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-27 | 0 | 1. R |
Event Narratives#
D
Patient 1
ALLEGEDLY, IN A 1997 LITERATURE ARTICLE, BY HANSRAJ ET AL. THE AUTHORS REPORT 12 IMPLANT FRACTURES AND 11 REVISIONS FOLLOWING MCP JOINT ARTHROPLASTY WITH SWANSON FINGER JOINT IMPLANTS.