FDA Adverse Event
Death
Summary report: N
PALACOS BONE CEMENT
MDR report key: 958465
·
Received November 30, 2007
Report
- Report Number
- 3002806535-2007-00003
- Event Type
- Death
- Date Received
- November 30, 2007
- Report Date
- April 1, 2005
- Manufacturer
- BIOMET UK LTD.
- Product Code
- LOD
- PMA / PMN Number
- P810020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A RETROSPECTIVE REVIEW OF FILE WAS PERFORMED ON OCTOBER 9, 2007. INITIAL ASSESSMENT DID NOT DETERMINE EVENT DETAILS TO BE REPORTABLE. DURING REVIEW, DETERMINATION WAS MADE THAT DETAILS PROVIDED MEET REPORTING REQUIREMENTS. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO USER FACILITY INFORMATION IS AVAILABLE. THIS REPORT FILED ON NOVEMBER 30, 2007.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT DIED SHORTLY AFTER AN EMERGENCY HEMIARTHROPLASTY. HOSPITAL SUGGESTED PATIENT MAY HAVE HAD AN ADVERSE REACTION TO THE CEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALACOS BONE CEMENT | LOD | BIOMET UK LTD. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Death |