D
Patient 1
SURGEON PERFORMING TOTAL KNEE REVISION AND DURING THE SURGERY THE IMPACTOR CHISEL FROM DEPUY BROKE.
MAUDE MDR 8222263
- MDR report key
- 8222263
- Report number
- MW5082873
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-12-10
- Date received
- 2019-01-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 999
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- P
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DEPUY IMPACT CHISEL | CHISEL, SURGICAL, MANUAL | DEPUY SYNTHES, INC. | FZO | 24210010000 | I | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-04 | 0 | 1. R |