FDA Adverse Event
Malfunction
Summary report: N
TRIATHLON PKR FEMUR #5 LM/RL
MDR report key: 2942309
·
Received January 8, 2013
Report
- Report Number
- 2249697-2013-90077
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Date of Event
- December 20, 2012
- Report Date
- December 20, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K071881
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER¿S ELECTRONIC COMPLAINT SYSTEMS.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGEON WAS PERFORMING A TKR AND IMPLANTED A SIZE 5 R LATERAL FEMUR AND, AFTER CEMENTING, HE REALIZED THAT IT STUCK PAST THE GUIDE MARK A METER OR TWO. WHEN PATIENT¿S KNEE FLEXED, THERE WAS RUBBING ON THE ANTERIOR ASPECT OF THE FEMORAL COMPONENT. REMOVED THE FEMORAL COMPONENT AND REPLACED WITH A SIZE 4, WHICH SOLVED THE PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10363 | TRIATHLON PKR FEMUR #5 LM/RL | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | DFMT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |