FDA Adverse Event
Injury
Summary report: N
SROM STM ST,36+6L NK,11X16X150
MDR report key: 1143650
·
Received August 28, 2008
Report
- Report Number
- 1818910-2008-03803
- Event Type
- Injury
- Date Received
- August 28, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 7, 2008
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER INCIDENTS RELATED TO LOOSENING AGAINST THE PROVIDED PRODUCT AND LOT CODES SINCE THEIR RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OR PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
Description of Event or Problem · 1
THE PT WAS REVISED BECAUSE OF LOOSENING OF THE FEMORAL SLEEVE AND STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SROM STM ST,36+6L NK,11X16X150 | 87MRA | MRA | DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS | NA | 1857500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |