FDA Adverse Event
Injury
Summary report: N
DUR MAR NEUT LINER 28IDX54OD
MDR report key: 2012562
·
Received February 24, 2011
Report
- Report Number
- 1818910-2011-03045
- Event Type
- Injury
- Date Received
- February 24, 2011
- Date of Event
- January 28, 2011
- Report Date
- January 28, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K994415
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
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
THE PT WAS REVISED BECAUSE OF DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUR MAR NEUT LINER 28IDX54OD | 87LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | X2TA61 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |