FDA Adverse Event
Malfunction
Summary report: N
ELITE PLUS S2 FLANGED HI OFS
MDR report key: 415390
·
Received September 5, 2002
Report
- Report Number
- 1818910-2002-00540
- Event Type
- Malfunction
- Date Received
- September 5, 2002
- Report Date
- September 5, 2002
- Manufacturer
- DEPUY INTERNATIONAL, LTD.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHEN THE BOX FOR THE SZ. 2 PRODUCT WAS OPENED; INSIDE WAS A SZ. 3 - PRODUCT CODE 1522-23-000/LOT XTE-38.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELITE PLUS S2 FLANGED HI OFS | TOTAL HIP PROSTHESIS | JDI | DEPUY INTERNATIONAL, LTD. | NA | XUK38 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |