N
Patient 1
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
MAUDE MDR 9647391
- MDR report key
- 9647391
- Report number
- 3010536692-2020-00089
- Event key
- 0
- Event type
- 3
- Date received
- 2020-01-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 5677 AIRLINE ROAD ARLINGTON TN 38002 US
- Phone
- 901-901-9018
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DYNASTY? COCR LINER | HIP COMPONENT | MICROPORT ORTHOPEDICS INC. | JDL | DLCOGC36 | DLCOGC36 | 039808007 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-30 | 0 | 1. R |
Event Narratives#
D
Patient 1
ALLEGEDLY, PATIENT UNDERWENT A REVISION SURGERY OF HER FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO METAL WEAR DEBRIS BETWEEN MODULAR COMPONENTS. PATIENT SUFFERED PERSISTENT PAIN, SWELLING, ELEVATED METAL IONS IN THE BLOODSTREAM, LOSS OF MOBILITY, AND DISCOMFORT.