FDA Adverse Event
Injury
Summary report: N
TRIATHLON PS FEM COMPONENT, CEMENTED
MDR report key: 1031233
·
Received April 16, 2008
Report
- Report Number
- 2249697-2008-00093
- Event Type
- Injury
- Date Received
- April 16, 2008
- Date of Event
- February 24, 2008
- Report Date
- March 11, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWY
- PMA / PMN Number
- K042993
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED. AT THIS TIME, IT CANNOT BE DETERMINED THAT THE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE NEED FOR THE PT'S REVISION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT FELL AND PRESENTED WITH A PERI PROSTHETIC FRACTURE. COMPONENTS REMOVED AND REPLACED WITH A REVISION TKR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON PS FEM COMPONENT, CEMENTED | IMPLANT | KWY | STRYKER ORTHOPAEDICS MAHWAH | NA | UVKI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |