FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 3940549
·
Received July 17, 2014
Report
- Report Number
- 0002249697-2014-02747
- Event Type
- Injury
- Date Received
- July 17, 2014
- Date of Event
- June 26, 2014
- Report Date
- June 26, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN TRIATHLON TIBIAL COMPONENT SIZE 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. PT DID NOT RELEASE PRODUCT.
Description of Event or Problem · 1
SURGEON REMOVED LOOSE TRIATHLON FEMORAL AND TIBIAL COMPONENTS AND REPLACED THEM WITH TRIATHLON TS COMPONENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418874 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |