FDA Adverse Event
Injury
Summary report: N
SROM STM ST, 36+8L NK, 18X13X160
MDR report key: 1870915
·
Received October 7, 2010
Report
- Report Number
- 1818910-2010-06820
- Event Type
- Injury
- Date Received
- October 7, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 7, 2010
- Manufacturer
- DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
- Product Code
- MRA
- PMA / PMN Number
- P040023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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 WAS REVISED TO ADDRESS INFECTION, WHICH CAUSED LOOSENING OF THE STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SROM STM ST, 36+8L NK, 18X13X160 | 87MRA | MRA | DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS | NA | 3161573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |