FDA Adverse Event
Injury
Summary report: N
TRIATHLON PS X3 TIBIAL INSERT
MDR report key: 3120486
·
Received May 20, 2013
Report
- Report Number
- 0002249697-2013-01709
- Event Type
- Injury
- Date Received
- May 20, 2013
- Date of Event
- April 25, 2013
- Report Date
- April 25, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- K051146
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.
Additional Manufacturer Narrative · 1
THE EVENT WAS NOT CONFIRMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION AND NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
THE PATIENT HAD A LOOSE KNEE SO WE WENT FROM A 9MM TO 13MM.
Description of Event or Problem · 1
THE PATIENT HAD A LOOSE KNEE SO WE WENT FROM A 9MM TO 13MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222693 | TRIATHLON PS X3 TIBIAL INSERT | IMPLANT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | MLN5MR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |