FDA Adverse Event
Injury
Summary report: N
PINN MAR+4 NEUT 36IDX52OD
MDR report key: 2010050
·
Received February 28, 2011
Report
- Report Number
- 1818910-2011-03130
- Event Type
- Injury
- Date Received
- February 28, 2011
- Date of Event
- January 29, 2011
- Report Date
- January 29, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K001534
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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
PT WAS REVISED TO ADDRESS RECURRENT DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINN MAR+4 NEUT 36IDX52OD | 87LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | E5RDL1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |