FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY FEMORAL HEAD
MDR report key: 3120287
·
Received May 20, 2013
Report
- Report Number
- 1818910-2013-17383
- Event Type
- Injury
- Date Received
- May 20, 2013
- Date of Event
- May 8, 2013
- Report Date
- June 14, 2013
- Manufacturer
- 1818910 DEPUY ORTHOPAEDICS, INC.
- Product Code
- KXA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
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.
Additional Manufacturer Narrative · 1
THIS IS A DUPLICATE REPORT OF 1818910-2013-17423. THIS REPORT, 1818910-2013-17383, WILL BE REJECTED. 1818910-2013-17423, WILL BE KEPT FOR INVESTIGATION PURPOSES.
Description of Event or Problem · 1
PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221669 | UNKNOWN DEPUY FEMORAL HEAD | FEMORAL HEAD | KXA | 1818910 DEPUY ORTHOPAEDICS, INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |