FDA Adverse Event Injury Summary report: N

MRH KNEE FEM M LFT

MDR report key: 3944436 · Received July 18, 2014

Report

Report Number: 0002249697-2014-02797
Event Type: Injury
Date Received: July 18, 2014
Date of Event: July 2, 2014
Report Date: July 2, 2014
Manufacturer: STRYKER ORTHOPAEDICS-MAHWAH
Product Code: KRO
PMA / PMN Number: K002552
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AN EVENT REGARDING REVISION SURGERY DUE TO FRACTURE OF THE STEM EXTENDER FROM THE FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW WAS SATISFACTORY. COMPLAINT HISTORY REVIEW INDICATES THAT THERE ARE NO OTHER SIMILAR EVENTS FOR THE LOT. THE REPORTED EVENT WAS NOT CONFIRMED. IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THIS CASE AS NO MEDICAL RECORDS OR EXPLANTED COMPONENTS WERE PROVIDED FOR THIS INVESTIGATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

Additional Manufacturer Narrative · 1

THE SALES REP NOTED THAT THE IMPLANT AND FURTHER INFORMATION IS NOT AVAILABLE DUE TO DOCTOR AND HOSPITAL POLICY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

IT WAS REPORTED DOCTOR DID A REVISION OF LEFT KNEE DUE TO LOOSE FEMORAL COMPONENTS. STEM SHEARED OFF.

Description of Event or Problem · 1

IT WAS REPORTED DOCTOR DID A REVISION OF LEFT KNEE DUE TO LOOSE FEMORAL COMPONENTS. STEM SHEARED OFF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
421730	MRH KNEE FEM M LFT	IMPLANT	KRO	STRYKER ORTHOPAEDICS-MAHWAH		S4BDB

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR		Hospitalization\| R