TRIATHLON PS X3 TIBIAL INSERT

Report

Report Number: 0002249697-2014-02987
Event Type: Injury
Date Received: August 5, 2014
Date of Event: July 10, 2014
Report Date: July 10, 2014
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: JWH
PMA / PMN Number: K051146
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MT, 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. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

Additional Manufacturer Narrative · 1

AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED, AS THE PATIENT ELECTED TO KEEP THE DEVICE. ANY ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

A POLY EXCHANGE WAS PERFORMED DUE TO INFECTION.

Description of Event or Problem · 1

A POLY EXCHANGE WAS PERFORMED DUE TO INFECTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
458004	TRIATHLON PS X3 TIBIAL INSERT	IMPLANT	JWH	STRYKER ORTHOPAEDICS-MAHWAH		METJ01

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Other