FDA Adverse Event
Injury
Summary report: N
PINN MAR +4 10D 36IDX56OD
MDR report key: 1945313
·
Received December 30, 2010
Report
- Report Number
- 1818910-2010-10742
- Event Type
- Injury
- Date Received
- December 30, 2010
- Date of Event
- December 2, 2010
- Report Date
- December 2, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K001534
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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
PATIENT WAS REVISED TO ADDRESS DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINN MAR +4 10D 36IDX56OD | 87LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | 228C21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention |