FDA Adverse Event
Injury
Summary report: N
SCORPIO NRG CR FEMORAL COMPONENT WITH HA SIZE 5
MDR report key: 911577
·
Received September 12, 2007
Report
- Report Number
- 2249697-2007-00127
- Event Type
- Injury
- Date Received
- September 12, 2007
- Date of Event
- July 17, 2007
- Report Date
- July 18, 2007
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DOCUMENTATION AND DHR REVIEW. EVENT WAS THE RESULT OF INCORRECT PRODUCT SELECTION DURING SURGERY.
Description of Event or Problem · 1
DURING TKA SURGERY FOR OA, A CR FEMORAL COMPONENT WAS IMPLANTED WHERE A PS TYPE WAS INTENDED TO USE. THE INDICATION WAS PS TYPE AND THE BONE WAS CUT AS PS TYPE. THE PATIENT WAS SUBSEQUENTLY REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPIO NRG CR FEMORAL COMPONENT WITH HA SIZE 5 | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | DENMLA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |