FDA Adverse Event
Injury
Summary report: N
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (UNI)
MDR report key: 2830992
·
Received November 1, 2012
Report
- Report Number
- 3005985723-2012-00221
- Event Type
- Injury
- Date Received
- November 1, 2012
- Date of Event
- October 5, 2012
- Report Date
- October 5, 2012
- Manufacturer
- MAKO SURGICAL
- Product Code
- NPJ
- PMA / PMN Number
- K090763
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SURGEON STATED THAT THE INFECTION WAS LIKELY NOT RELATED TO THE MAKO PRODUCT. AN INTERNAL EVAL OF THE ISSUE IS ONGOING.
Description of Event or Problem · 1
THE SURGEON HAD PERFORMED A MAKOPLASTY PARTIAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2012. THE PT PRESENTED WITH A POST-OPERATIVE INFECTION, AND THE SURGEON PERFORMED AN INCISION AND DRAINAGE (I&D) PROCEDURE AND A SWAP OF THE ONLAY INSERT COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (UNI) | COMPARTMENTAL KNEE SYSTEM | NPJ | MAKO SURGICAL | 180708-1 | 12020412-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |