N
Patient 1
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED
MAUDE MDR 9817320
- MDR report key
- 9817320
- Report number
- 3010536692-2020-00211
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-11
- 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 | COCR TRANSCEND? FEMORAL HEAD 32MM SLT TAPER MEDIUM | HIP COMPONENT | MICROPORT ORTHOPEDICS INC. | JDL | 26000022 | 26000022 | 15063261764012 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-11 | 0 | 1. R |
Event Narratives#
D
Patient 1
ALLEGEDLY, PATIENT FELL AGAIN, DISLOCATED AND THE BIPOLAR DISASSOCIATED. THERE HAS NOT BEEN A CONFIRMED REVISION FOR THIS INCIDENT. REFERENCE (B)(4) AS A PREVIOUS INCIDENT FOR THIS PATIENT.