FDA Adverse Event
Injury
Summary report: N
RESTORIS MCK ONLAY TIBIAL INSERT
MDR report key: 2031478
·
Received January 18, 2011
Report
- Report Number
- 3005985723-2011-00004
- Event Type
- Injury
- Date Received
- January 18, 2011
- Date of Event
- December 16, 2010
- Report Date
- January 18, 2011
- Manufacturer
- MAKO SURGICAL
- Product Code
- HSX
- PMA / PMN Number
- K081867
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REVISED IMPLANTS WERE NOT RETURNED FOR INVESTIGATION. POST-OP X-RAY WERE NOT AVAILABLE. THE SURGEON INDICATED THE REVISION WAS DUE TO INFECTION. BASED ON THE SURGEON'S DESCRIPTION OF THE CAUSE OF THE REVISION, THE RIO SYSTEM WORKED AS EXPECTED.
Description of Event or Problem · 1
REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORIS MCK ONLAY TIBIAL INSERT | UNICONDYLAR KNEE SYSTEM | HSX | MAKO SURGICAL | 180706-1 | 12160410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |