FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY BROACH
MDR report key: 3077321
·
Received April 25, 2013
Report
- Report Number
- 1818910-2013-04418
- Event Type
- Injury
- Date Received
- April 25, 2013
- Report Date
- February 15, 2012
- Manufacturer
- DEPUY WARSAW
- Product Code
- LXH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
LITIGATION PAPERS ALLEGE THE PATIENT HAS SUFFERED PAIN, METALLOSIS, AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT. PLAINTIFFS PRELIMINARY DISCLOSURE (PPD) WITH OPERATIVE REPORT INDICATED A SMALL CRACK WAS NOTED IN THE CALCAR WHEN BROACHING DURING IMPLANT SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 179699 | UNKNOWN DEPUY BROACH | BROACH | LXH | DEPUY WARSAW | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |