FDA Adverse Event
Malfunction
Summary report: N
15MM PRESS FIT FLUTED STEM
MDR report key: 1872180
·
Received October 13, 2010
Report
- Report Number
- 2249697-2010-01352
- Event Type
- Malfunction
- Date Received
- October 13, 2010
- Date of Event
- September 21, 2010
- Report Date
- September 21, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LZO
- PMA / PMN Number
- K031217
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PREPARED AS PER TECHNIQUE AND THE STEM SLID IN AND OUT. DIDN'T GET PRESSFIT SO DR IS QUESTIONING THE SPECS ON THE IMPLANT. USED THE GMRS PRESSFIT REAMER TO PREPARE THE CANAL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 15MM PRESS FIT FLUTED STEM | IMPLANT | LZO | STRYKER ORTHOPAEDICS MAHWAH | NA | 7N4083B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |