FDA Adverse Event
Malfunction
Summary report: N
KX PLUS FEM CONDY NONPOR XLG
MDR report key: 177480
·
Received July 14, 1998
Report
- Report Number
- 9610726-1998-00092
- Event Type
- Malfunction
- Date Received
- July 14, 1998
- Report Date
- July 13, 1998
- Manufacturer
- HOWMEDICA INC.
- Product Code
- HSA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE TRIAL FIT WELL; HOWEVER, THE IMPLANT APPEARED TO BE TOO LARGE. IT SEEMED TO BE CLOSER TO AN XXL IN SIZE. THE COMPONENT WAS IMPLANTED IN THE PT. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KX PLUS FEM CONDY NONPOR XLG Implant | IMPLANT | HSA | HOWMEDICA INC. | NA | LJKPP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |