D
Patient 1
IT WAS REPORTED THAT A LEFT HIP REVISION WAS PERFORMED DUE TO SEVERE PAIN; DECREASED MOBILITY; SHEDDING OF METAL DEBRIS INTO THE BLOODSTREAM; TISSUE DAMAGE; AND ELEVATED COBALT AND CHROMIUM LEVELS.
MAUDE MDR 9908389
- MDR report key
- 9908389
- Report number
- 3005975929-2020-00095
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-08-23
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DR. SARAH FREESTONE
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACETABLR CUP HAP | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING | SMITH & NEPHEW ORTHOPAEDICS LTD | NXT | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. H; 2. R |