FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 2974064
·
Received February 22, 2013
Report
- Report Number
- 0002249697-2013-00750
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- November 1, 2009
- Report Date
- January 31, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. REMAINS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS COMPLAINTS OF CLICKING AND SQUEAKING NOISE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAS COMPLAINTS OF CLICKING AND SQUEAKING NOISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77801 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | LXH | STRYKER ORTHOPAEDICS-MAHWAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |