FDA Adverse Event
Injury
Summary report: N
SCORPIO NRG CR FEMORAL COMPONENT LEFT #5
MDR report key: 2142408
·
Received June 21, 2011
Report
- Report Number
- 2249697-2011-00915
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 29, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K042343
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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
IT WAS REPORTED THAT, "THE PT HAD A KNEE PAIN AND A UNSTABLE FEELING ON HER REPLACED KNEE. THEREFORE, THE SURGEON PERFORMED A REVISION TKA ON MAY 13TH. THE SURGEON COULD REMOVE THE FEMORAL COMPONENT WITH HIS HAND WITHOUT ANY STRUGGLES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO NRG CR FEMORAL COMPONENT LEFT #5 | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |