FDA Adverse Event
Injury
Summary report: N
ALTRX +4 NEUT 32IDX50OD
MDR report key: 2011392
·
Received March 4, 2011
Report
- Report Number
- 1818910-2011-03508
- Event Type
- Injury
- Date Received
- March 4, 2011
- Date of Event
- February 5, 2011
- Report Date
- February 5, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K072963
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 REVISED FOR DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRX +4 NEUT 32IDX50OD | 87 LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | EL2C91000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |