FDA Adverse Event
Injury
Summary report: N
HIP FRACTURE STEM IMPLANT #2
MDR report key: 465704
·
Received June 11, 2003
Report
- Report Number
- 2219689-2003-00061
- Event Type
- Injury
- Date Received
- June 11, 2003
- Date of Event
- January 29, 2002
- Report Date
- May 15, 2003
- Manufacturer
- HOWMEDICA OSTEONICS CORP.
- Product Code
- KWI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO PFIZER INC., THROUGH A LEGAL CLAIM FILED BY PATIENT'S ATTORNEY THAT PATIENT SUSTAINED FRACTURE OF THE STEM OF THE LEFT IN MID-POINT WHICH REQUIRED REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIP FRACTURE STEM IMPLANT #2 | IMPLANT | KWI | HOWMEDICA OSTEONICS CORP. | NA | CVNTB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |