MAUDE MDR 8748848
- MDR report key
- 8748848
- Report number
- 1220246-2019-01191
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-10-02
- Date received
- 2019-07-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | IBAL PATELLA IMPL DOME,37X 10 MM | PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | ARTHREX, INC. | KRR | IBAL PATELLA IMPL DOME,37X 10 MM | AR-504-PSD0 | 113601225 | | | | N
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-07-01 | 0 | 1. O
|
Event Narratives#
No narrative records found.