FDA Adverse Event
Injury
Summary report: N
PFC SIGMARP CV TB/IN S3 10.0
MDR report key: 636673
·
Received September 22, 2005
Report
- Report Number
- 1818910-2005-01823
- Event Type
- Injury
- Date Received
- September 22, 2005
- Date of Event
- August 31, 2005
- Report Date
- August 31, 2005
- Manufacturer
- DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT WAS REVISED REPORTEDLY DUE TO INFECTION, POLY WAS SWAPPED. DOI: 7/28/2005 DOR: 8/24/2005. FURTHER FOLLOW-UP DISCOVERED PT HAS TYPE 2 DIABETES AND HAS HAD SEVERAL SURGICAL/MEDICAL INTERVENTION DUE TO INFECTION. DOI: 6/11/2004 DOR: 7/28/2005 THE POLY INSERT WAS SWAPPED AND DOI: 8/24/2005 DOR: 8/31/2005 WHERE ALL COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFC SIGMARP CV TB/IN S3 10.0 | TOTAL KNEE PROSTHESIS | JWH | DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. | NA | 1896387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |