FDA Adverse Event
Injury
Summary report: N
SCORPIO NRG X3 PS TIBIAL INSERT #7 12MM
MDR report key: 2182475
·
Received July 19, 2011
Report
- Report Number
- 2249697-2011-01077
- Event Type
- Injury
- Date Received
- July 19, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 27, 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
- KN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE PATIENT COMPLAINED SEVERE KNEE PAIN AND INSTABILITY AFTER THE PATIENT HEARD SOME SOUND IN KNEE ONE MONTH AGO. SO DR. (B)(6) TESTED ROM AND STABILITY IN KNEE. DR. (B)(6) GUESSED POST FX OR MCL LOOSENING, AND SO HE DECIDED REVISION (LINER CHANGE OR TIBIAL REVISION), AND FOUND OUT POST FX IN INTRA-OPERATING. SO DR. (B)(6) DID REPLACEMENT OF LINER IN RT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO NRG X3 PS TIBIAL INSERT #7 12MM | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | MJAX2R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |