FDA Adverse Event
Injury
Summary report: N
CHARNLEY OGEE CUP 22.225/40MM
MDR report key: 511517
·
Received February 13, 2004
Report
- Report Number
- 1818910-2004-00085
- Event Type
- Injury
- Date Received
- February 13, 2004
- Date of Event
- November 1, 2003
- Report Date
- January 14, 2004
- Manufacturer
- DEPUY ORTHOPAEDICS, INC.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MHRA RECEIVED A REPORT OF A FRACTURED ACETABULAR CUP DIRECT FROM THE PATIENT'S FAMILY MEMBER IN AUGUST 2003, MHRA REFERENCE 2003/007/030/151/004. IT APPEARS THAT THE CUP WAS OBSERVED TO HAVE BROKEN IN FEBURARY 2003 AFTER THE PATIENT PRESENTED WITH PAIN AND DECREASED MOBILITY. AN AVATAR STEM USED IN CONBINATION WITH THE CUP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHARNLEY OGEE CUP 22.225/40MM | TOTAL HIP REPLACEMENT | JDI | DEPUY ORTHOPAEDICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |