FDA Adverse Event
Injury
Summary report: N
UNK JNJ KNEE
MDR report key: 516510
·
Received March 18, 2004
Report
- Report Number
- 1818910-2004-00242
- Event Type
- Injury
- Date Received
- March 18, 2004
- Date of Event
- November 1, 2002
- Report Date
- February 16, 2004
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- HSH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE LEGAL PAPERS STATE THIS PT WAS IMPLANTED WITH A J&J KNEE APPROX 11 PRIOR TO REVISION OF THE POLY. IN 2002 THE ENTIRE KNEE WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK JNJ KNEE | TOTAL KNEE REPLACEMENT | HSH | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |