FDA Adverse Event
Death
Summary report: N
SOL 13.5 STD 8.0 FULL PC 12/14
MDR report key: 512668
·
Received February 23, 2004
Report
- Report Number
- 1818910-2004-00159
- Event Type
- Death
- Date Received
- February 23, 2004
- Date of Event
- February 12, 2004
- Report Date
- February 12, 2004
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- LPH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE TOTAL HIP PATIENT, SUDDENLY EXPERIENCED CARDIAC ARREST AND EXPIRED AFTER THE NON-CEMENTED STEM WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOL 13.5 STD 8.0 FULL PC 12/14 | TOTAL HIP REPLACEMENT | LPH | DEPUY ORTHOPAEDICS, INC. | NA | X47GE1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Death |