FDA Adverse Event
Injury
Summary report: N
SOL SYS 1.5X12.0 CALCAR 12/14
MDR report key: 1884749
·
Received October 22, 2010
Report
- Report Number
- 1818910-2010-07274
- Event Type
- Injury
- Date Received
- October 22, 2010
- Date of Event
- September 23, 2010
- Report Date
- September 23, 2010
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- PMA / PMN Number
- K953703
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 A BROKEN STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOL SYS 1.5X12.0 CALCAR 12/14 | 87LPH | LPH | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |