FDA Adverse Event
Malfunction
Summary report: N
TIBIAL ALIGNMENT ANKLE CLAMP EM
MDR report key: 2003078
·
Received February 8, 2011
Report
- Report Number
- 2249697-2011-00134
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- 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, "TIBIAL ALIGNMENT ANKLE CLAMP EM TYPE WAS BROKEN WHEN REMOVED THE TIBIAL RESECTION ASSEMBLY DURING TKRA SURGERY WITH TRIATHLON."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TIBIAL ALIGNMENT ANKLE CLAMP EM | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | N2C11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |