FDA Adverse Event
Injury
Summary report: N
CENTRAX DURATION 22.2MM X 52MM
MDR report key: 1203008
·
Received October 17, 2008
Report
- Report Number
- 2249697-2008-00319
- Event Type
- Injury
- Date Received
- October 17, 2008
- Date of Event
- September 22, 2008
- Report Date
- September 22, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K861105
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATIENT RECEIVED BHA SURGERY IN 2004. WHEN THE PATIENT WAS USING THE TOILET IN 2008, HE FELT A GREAT DEAL OF PAIN, AND WENT TO HOSPITAL IMMEDIATELY. AFTERWARD, THE SURGEON FOUND THE INNER HEAD DISSOCIATED FROM THE CENTRAX ON THE X-RAY. THEN, THE SURGEON PERFORMED REVISION SURGERY TO CHANGE THE NEW CENTRAX INSTEAD OF DISSOCIATED CENTRAX."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRAX DURATION 22.2MM X 52MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |