FDA Adverse Event
Injury
Summary report: N
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
MDR report key: 3030581
·
Received March 20, 2013
Report
- Report Number
- 3005985723-2013-00012
- Event Type
- Injury
- Date Received
- March 20, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 19, 2013
- Manufacturer
- MAKO SURGICAL
- Product Code
- HRY
- PMA / PMN Number
- K090763
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION WAS INITIATED BY MAKO SURGICAL WITH REGARD TO THIS EVENT. THE EVALUATION IS IN PROGRESS, AND NO PRELIMINARY INFORMATION IS CURRENTLY AVAILABLE.
Description of Event or Problem · 1
THE SURGEON HAS PERFORMED A PARTIAL KNEE ARTHROPLASTY USING MAKO'S ROBOTIC ARM INTERFACE ORTHOPEDIC SYSTEM (RIO) AND THE RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (MCK) ON (B)(6) 2012. THE PATIENT EXPERIENCED LOOSENING OF THE FEMORAL COMPONENT AND UNDERWENT A TOTAL KNEE REVISION ON THE DATE OF EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116107 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM | COMPARTMENTAL KNEE PROSTHESIS SYSTEM | HRY | MAKO SURGICAL | 180406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | ROBOTIC ARM INTERFACE ORTHOPEDIC SYSTEM (RIO) |