FDA Adverse Event
Injury
Summary report: N
PFC SIGMA C/S NPOR FEM LT SZ 4
MDR report key: 1903334
·
Received November 16, 2010
Report
- Report Number
- 1818910-2010-07990
- Event Type
- Injury
- Date Received
- November 16, 2010
- Date of Event
- September 1, 2010
- Report Date
- October 17, 2010
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JWH
- PMA / PMN Number
- K950010
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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
THE PATIENT WAS REVISED TO ADDRESS PAIN AND INFLAMMATION. DURING SURGERY, THE SURGEON FOUND THREE POLYETHYLENE PLUGS WERE BROKEN OFF THE KNEE PROSTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMA C/S NPOR FEM LT SZ 4 | 87 JWH | JWH | DEPUY INTERNATIONAL, LTD. | NA | 2581216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |