FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY FEMORAL HEAD
MDR report key: 2895802
·
Received January 3, 2013
Report
- Report Number
- 1818910-2013-00752
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- August 24, 2010
- Manufacturer
- DEPUY WARSAW
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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 POLY WEAR. UPDATE - (B)(4) 2012 - MEDICAL RECORDS WERE RECEIVED VIA EMAIL. THE REVISION OPERATIVE REPORT INDICATES THAT THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. THE FEMORAL HEAD WAS ADDED TO THE COMPLAINT. (LEFT HIP).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2905 | UNKNOWN DEPUY FEMORAL HEAD | FEMORAL HEAD | KWY | DEPUY WARSAW | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention |