FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 3781186
·
Received April 30, 2014
Report
- Report Number
- 0002249697-2014-01692
- Event Type
- Malfunction
- Date Received
- April 30, 2014
- Date of Event
- July 1, 2013
- Report Date
- April 4, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LZO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CATALOG NUMBER, LOT CODE AND COMPLETE DEVICE DESCRIPTION WAS NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN HFX STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE V40 FEM HEAD COULD NOT MATCH UP WITH HFX STEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259677 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | LZO | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |