D
Patient 1
IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE TRIAL INSERT CRACKED IN HALF WHILE INSERTING. NO INJURIES OR DELAYS REPORTED. A BACKUP DEVICE WAS AVAILABLE.
MAUDE MDR 9697069
- MDR report key
- 9697069
- Report number
- 1020279-2020-00514
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-29
- Date received
- 2020-02-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- DR. SARAH FREESTONE
- Address
- 1450 BROOKS ROAD MEMPHIS TN 38116 US
- Phone
- 44-44-0447
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GII PS HI FLEX ISRT TR S1-2 9 | TRAY, SURGICAL, INSTRUMENT | SMITH & NEPHEW, INC. | FSM | 71430401 | 71430401 | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-02-11 | 0 |