FDA Adverse Event Malfunction Summary report: N

NEXGEN STEM EXTENSION

MDR report key: 2935628 · Received January 23, 2013

Report

Report Number: 1822565-2013-00144
Event Type: Malfunction
Date Received: January 23, 2013
Date of Event: December 20, 2012
Report Date: December 28, 2012
Manufacturer: ZIMMER, INC.
Product Code: NJL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE LCCK SURGICAL TECHNIQUE GIVES INSTRUCTIONS FOR PROPERLY ASSEMBLING THE LCCK ARTICULAR SURFACE, TIBIAL PLATE, AND STEM EXTENSION. THE SURGEON IS INSTRUCTED TO FOLLOW EITHER THE "BACK-TABLE" OR INTRA OPERATIVE METHOD. THE TECHNIQUES CALL FOR THE SURGEON TO STRIKE THE STEM EXTENSION ONCE WITH A TWO POUND MALLET TO ASSURE FULL SEATING OF THE TAPER. IF THE SURGEON DID NOT APPLY THE PROPER FORCE OR IMPACTED THE TAPER MORE THAN ONCE, IT IS POSSIBLE THAT THE TAPER CONNECTION COULD HAVE LOOSENED. IN THIS CASE THE SURGEON STATES THAT HE FOLLOWED THE SURGICAL TECHNIQUE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE FOR THE REPORTED ISSUE CANNOT BE CONCLUSIVELY DETERMINED. AS RETURNED THE STEM EXTENSION WAS FOUND TO MEET SPECIFICATIONS AS MEASURED; SCRATCHES WERE OBSERVED ON THE TAPER. THREADS WERE TESTED AND FOUND TO BE ACCEPTABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND CONFORMING, INDICATING THE DEVICES WERE MANUFACTURED, INSPECTED AND PACKAGED TO SPECIFICATIONS.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE STEM EXTENSION DISENGAGED AFTER INSERTION, PREVENTING ENGAGEMENT OF ARTICULAR SURFACE LOCKING SCREWS. THE COMPONENT WAS REMOVED AND A NEW CONSTRUCT WAS USED TO COMPLETE THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
33399	NEXGEN STEM EXTENSION		NJL	ZIMMER, INC.		60387379

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR