FDA Adverse Event
Injury
Summary report: N
SCORPIO NRG X3 PS TIBIAL INSERT #9 15MM
MDR report key: 2001672
·
Received February 22, 2011
Report
- Report Number
- 2249697-2011-00206
- Event Type
- Injury
- Date Received
- February 22, 2011
- Date of Event
- February 4, 2011
- Report Date
- February 4, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K071991
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "REVISION OF THE KNEE WAS REQUIRED. POST OF INSERT WAS BROKEN AND SURGEON HAS REVISED THE INSERT AND THE PATELLA."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO NRG X3 PS TIBIAL INSERT #9 15MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | LRAMDE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |