D
Patient 1
ALLEGEDLY THE PATIENT WAS REVISED DUE TO MOM COMPLICATIONS: SEVERE HIP PAIN; ELEVATED METAL LEVELS OF COBALT AND CHROMIUM; EVIDENCE OF SUBSIDENCE OF THE STEM; METALLOSIS; AND CLICKING (RIGHT).
MAUDE MDR 9664353
- MDR report key
- 9664353
- Report number
- 3010536692-2019-01022
- Event key
- 0
- Event type
- 3
- Date received
- 2020-02-04
- 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 | PROFEMUR? RENAISSANCE ? STEM | HIP COMPONENT | MICROPORT ORTHOPEDICS INC. | JDL | PLS0S415 | PLS0S415 | 088580621 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-04 | 0 | 1. R |