FDA Adverse Event
Injury
Summary report: N
TRIATHLON PS X3 TIBIAL INSERT
MDR report key: 3023866
·
Received March 27, 2013
Report
- Report Number
- 0002249697-2013-01119
- Event Type
- Injury
- Date Received
- March 27, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 6, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K051146
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A POLY EXCHANGE ON THE RIGHT KNEE BECAUSE COULD NOT REACH FULL EXTENSION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A POLY EXCHANGE ON THE RIGHT KNEE BECAUSE COULD NOT REACH FULL EXTENSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127060 | TRIATHLON PS X3 TIBIAL INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | MLP5L2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |