FDA Adverse Event
Injury
Summary report: N
CORAIL2 NON COL HO SIZE 12
MDR report key: 1080891
·
Received July 22, 2008
Report
- Report Number
- 1818910-2008-02708
- Event Type
- Injury
- Date Received
- July 22, 2008
- Date of Event
- April 22, 2008
- Report Date
- June 23, 2008
- Manufacturer
- DEPUY FRANCE S.A.
- Product Code
- LZO
- PMA / PMN Number
- K042992
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- 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
PATIENT HAD FALLEN ON THIS HIP IN 2007, CAUSING ONGOING PAIN. RADIOLOGICAL FINDINGS SHOW A 4MM LINEAR LUCENCY PARALLELING THE ANTERIOR ASPECT OF THE FEMORAL STEM OF THE PROSTHESIS WHICH MAY PRESENT LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORAIL2 NON COL HO SIZE 12 | 87LZO | LZO | DEPUY FRANCE S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |