FDA Adverse Event Injury Summary report: N

OS KNEE UNIVERSAL (SOFTWARE)

MDR report key: 1309894 · Received February 9, 2009

Report

Report Number: 9617840-2009-00001
Event Type: Injury
Date Received: February 9, 2009
Date of Event: January 7, 2009
Report Date: February 9, 2009
Manufacturer: ZIMMER CAS
Product Code: HAW
PMA / PMN Number: K060336
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE COMPUTER LOGS AS RECORDED DURING THE SURGERY WERE OBTAINED FOR EVALUATION. THE ANALYSIS OF THESE LOGS INDICATED THAT THE FEMORAL REFERENCE WAS LIKELY DISPLACED AS WAS REPORTED AND WOULD HAVE CORRESPONDINGLY AFFECTED THE ALIGNMENT DATA. WARNINGS ARE INCLUDED IN THE USER INSTRUMENTS WITH RESPECT TO ENSURING THAT THE BONE REFERENCES ARE NOT DISPLACED AFTER THEIR INITIAL PLACEMENT.

Description of Event or Problem · 1

DURING A NAVIGATED TKR SURGERY, AFTER HAVING CUT THE DISTAL FEMUR THE SURGEON ASSESSED THAT THE CUT WAS APPROXIMATELY IN FIVE DEGREES OF VALGUS WHEREAS HE HAD ALIGNED THE CUTTING BLOCK USING THE NAVIGATION SYSTEM FOR A CUT AT ZERO DEGREES OF VALGUS (I.E. NEUTRAL HIP-KNEE-ANKLE ALIGNMENT). THE SURGEON THEN CORRECTED THE ALIGNMENT BY RE-CUTTING THE DISTAL FEMUR BY ABOUT TWO DEGREES AND BY USING A BONE WEDGE ON THE DISTAL FEMUR TO FURTHER ADJUST THE ALIGNMENT. IT WAS ALSO NOTED TOWARDS THE END OF THE SURGERY THAT THE FIXATION PINS OF THE NAVIGATION REFERENCE FOR THE FEMUR WERE BENT AND THE REFERENCE DISPLACED FROM ITS INITIAL LOCATION. THIS REFERENCE, WHICH IS RIGIDLY AFFIXED TO THE FEMUR BY THE SURGEON, IS USED BY THE NAVIGATION SYSTEM TO TRACK THE LOCATION OF THE FEMUR AND THE RELATIVE ALIGNMENT OF THE CUTTING BLOCK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OS KNEE UNIVERSAL (SOFTWARE)	HAW (STEREOTAXIC INSTRUMENT)	HAW	ZIMMER CAS	UNITKR-2.2	UNITKR-2.2.3.1

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention