FDA Adverse Event
Injury
Summary report: N
CENTRAX DURATION 26MM X 55MM
MDR report key: 2012911
·
Received March 1, 2011
Report
- Report Number
- 2249697-2011-00224
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 3, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K780317
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "WHEN THE PATIENT WAS SITTING ON A CHAIR, THE CENTRAX CAME OFF FROM THE FEMORAL HEAD. THE SURGEON SUCCEEDED TO REDUCE IT WINCHING A PORTABLE X-RAY DEVICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRAX DURATION 26MM X 55MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R |