FDA Adverse Event
Injury
Summary report: N
PINN MAR NEUT 28IDX50OD
MDR report key: 1842570
·
Received September 17, 2010
Report
- Report Number
- 1818910-2010-06218
- Event Type
- Injury
- Date Received
- September 17, 2010
- Date of Event
- August 19, 2010
- Report Date
- August 19, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- LPH
- PMA / PMN Number
- K001534
- 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.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PT WAS REVISED AFTER SHE SLIPPED ON A DOCK AT THE LAKE BUT DID NOT FALL, CAUSING DISLOCATION. THE POLY WAS NOT IN A LOCKED STATE WHEN THE WOUND WAS OPENED. ABNORMAL POLY WEAR WAS FOUND, AS WELL AS OSTEOLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PINN MAR NEUT 28IDX50OD | 87LPH | LPH | DEPUY ORTHOPAEDICS INC US | NA | Y5CG11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |