FDA Adverse Event
Injury
Summary report: N
STER TROC LAG SCR 100MM
MDR report key: 5124820
·
Received April 6, 2004
Report
- Report Number
- 1818910-2004-00261
- Event Type
- Injury
- Date Received
- April 6, 2004
- Date of Event
- March 11, 2003
- Report Date
- March 17, 2004
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- OVZ
- Removal / Correction Number
- Z390-4Z505-4
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO FDA: 04/05/2004. 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
SURGERY WAS DONE ON (B)(6) 2004 TO REMOVE THE TROCHANTERIC NAIL AND LAG SCREW AND REPLACE IT WITH A BIOPOLAR PROSTHESIS. THE ORIGINAL TROCHANTERIC NAIL FIXATION WAS DONE (B)(6) 2003 TO REPAIR A FRACTURED R. HIP. ON (B)(6) 2003 THE PATIENT WAS RETURNED TO THE O.R. TO REPOSITION THE MIGRATING LAG SCREW. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STER TROC LAG SCR 100MM | TRAUMA FIXATION | OVZ | DEPUY ORTHOPAEDICS, INC. | NA | 293716000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization |