FDA Adverse Event
Death
Summary report: N
STER H TROC NAIL 380X9X130
MDR report key: 1222363
·
Received November 4, 2008
Report
- Report Number
- 1818910-2008-05283
- Event Type
- Death
- Date Received
- November 4, 2008
- Date of Event
- September 23, 2008
- Report Date
- October 25, 2008
- Manufacturer
- DEPUT ACE S.A. 'R.L
- Product Code
- HSB
- PMA / PMN Number
- K013563
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
ATN IMPLANTED IN 2008. PATIENT WAS REVISED TO ADDRESS FAILURE OF THE ATN NAIL. THE FEMORAL HEAD COLLAPSED AND ROTATED ROUND THE LAG SCREW, SO THE NAIL WAS REVISED. PATIENT SUBSEQUENTLY DIED THE FOLLOWING MONTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STER H TROC NAIL 380X9X130 | 87HSB | HSB | DEPUT ACE S.A. 'R.L | NA | DHCCDB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Death |