FDA Adverse Event
Injury
Summary report: N
RESTORIS MCK ONLAY TIBIAL BASEPLATE
MDR report key: 2192440
·
Received June 3, 2011
Report
- Report Number
- 3005985723-2011-00013
- Event Type
- Injury
- Date Received
- June 3, 2011
- Date of Event
- April 22, 2011
- Report Date
- May 20, 2011
- Manufacturer
- MAKO SURGICAL
- Product Code
- HAW
- PMA / PMN Number
- K081867
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REVISED IMPLANTS WERE NOT RETURNED FOR INVESTIGATION. POST-OP X-RAYS WERE NOT REVIEWED. THE REVISION WAS CAUSED DUE TO LOOSENING OF THE TIBIAL IMPLANT, AND THE REVISING SURGEON INDICATED THE REASON FOR LOOSENING WAS CEMENTING TECHNIQUE AND NOT A PRODUCT FAILURE. THERE IS NO EVIDENCE INDICATING A FAILURE OF THE IMPLANT OR THE SYSTEM.
Description of Event or Problem · 1
REVISION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORIS MCK ONLAY TIBIAL BASEPLATE | UNICONDYLAR KNEE SYSTEM | HAW | MAKO SURGICAL | 180606 | 26130410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |