FDA Adverse Event
Injury
Summary report: N
SUMMIT POR TAPER SZ7 HI OFF
MDR report key: 2002770
·
Received February 17, 2011
Report
- Report Number
- 1818910-2011-02383
- Event Type
- Injury
- Date Received
- February 17, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 18, 2011
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- MRA
- PMA / PMN Number
- P040023
- 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
SUMMIT POROUS STEM WAS LOOSE AND SUBSIDED APPROX 1 CM WITHIN 2 WEEKS. SCHEDULED FOR REVISION TO CEMENTED STEM ON (B)(6) 2011. ON (B)(6) 2011, PT FELL, FRACTURING OFF LESSER TROCHANTER, SO STEM WAS REVISED TO A WAGNER-TYPE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUMMIT POR TAPER SZ7 HI OFF | 87MRA | MRA | DEPUY ORTHOPAEDICS, INC. | NA | E5GCC1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |