FDA Adverse Event Injury Summary report: N

X3 TRIATHLON CS INS SIZE4 11MM

MDR report key: 2924570 · Received January 22, 2013

Report

Report Number: 0002249697-2013-00108
Event Type: Injury
Date Received: January 22, 2013
Date of Event: January 3, 2013
Report Date: January 3, 2013
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: JWH
PMA / PMN Number: K063423
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DHR REVIEW AND STERILITY CERTIFICATE REVIEW FOR THE REPORTED LOT WAS SATISFACTORY. CHR REVIEW DETERMINED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT OR STERILE LOT. MEDICAL REVIEW WAS NOT PERFORMED AS NO MEDICAL RECORDS OR PATHOLOGY REPORTS WERE PROVIDED. BASED ON THE RESULTS OF THE EVALUATION, INSUFFICIENT INFORMATION WAS RECEIVED TO CONFIRM THE REPORTED EVENT OR DETERMINE A CAUSE. IT IS NOTED THAT WHEN THE DOUBLE BARRIER PACKAGING IS OPENED, THE STERILITY OF ANY DEVICE BECOMES A FUNCTION OF HANDLING AND SURGICAL TECHNIQUE AND IS BEYOND STRYKER'S CONTROL. FURTHER EVIDENCE SUBSTANTIATING THE CAUSE OF THE INFECTION WOULD BE NECESSARY TO DETERMINE THE ROOT CAUSE.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO MANUFACTURER.

Description of Event or Problem · 1

IT WAS REPORTED, " I/D WASHOUT FOR INFECTION, LINER REMOVED. WASHOUT AND NEW TIBIAL INSERT IMPLANTED.

Description of Event or Problem · 1

IT WAS REPORTED, " I/D WASHOUT FOR INFECTION, LINER REMOVED. WASHOUT AND NEW TIBIAL INSERT IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
29787	X3 TRIATHLON CS INS SIZE4 11MM	IMPLANT	JWH	STRYKER ORTHOPAEDICS-MAHWAH		LC5928

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR		Required Intervention