D
Patient 1
ORIGINAL SURGERY: 3/19/98. ALLEGEDLY PATIENT HAD MEDIAL BONE LOSS UNDER TIBIAL PLATEAU. TIBIA COLLAPSED. CUSTOM IMPLANT WAS MADE.
MAUDE MDR 219354
- MDR report key
- 219354
- Report number
- 1043534-1999-00034
- Event key
- 0
- Event type
- 3
- Date of event
- 1999-01-26
- Date received
- 1999-04-14
- 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#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DURAMER BRAND ADVANTIM LSI TIBIAL INSERT | KNEE COMPONENT | WRIGHT MEDICAL TECHNOLOGY, INC. | KRP | NA | 1880-3210 | 087A069336 | Y | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1999-04-14 | 0 | 1. R |