FDA Adverse Event Malfunction Summary report: N

NEXGEN LEGCAY LCCK ARTICULAR SURFACE

MDR report key: 1915241 · Received November 2, 2010

Report

Report Number: 1822565-2010-01050
Event Type: Malfunction
Date Received: November 2, 2010
Date of Event: October 1, 2010
Report Date: October 5, 2010
Manufacturer: ZIMMER INC
Product Code: JWH
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE INSTRUMENT USED TO LOCK THE SCREW IS UNK. OFF AXIS INSERTION COULD BE A PROBABLE REASON, HOWEVER, A DEFINITE CAUSE CANNOT BE DETERMINED WITHOUT THE DEVICE/FRACTURE ANALYSIS.: EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

Description of Event or Problem · 1

IT IS REPORTED THAT WHILE TIGHTENING A LOCKING SCREW WITH TORQUE WRENCH ON A 20MM LCCK SURFACE, THE SCREW SNAPPED. THE SURGEON TRIED TO REMOVE THE SCREW BY VARIOUS MEANS, BUT WAS UNABLE TO GET THE SCREW TO BACK OUT. THE SURGEON THEN IMPLANTED A 20MM LPS SURFACE, WHICH ALSO REQUIRES A LOCKING SCREW. THE LOCKING SCREW THAT WAS REQUIRED FOR THIS LPS SURFACE COULD NOT BE USED BECAUSE OF THE BROKEN SCREW. SO AT THIS POINT, THE SURGEON FELT THAT THE LPS SURFACE WAS THE BEST ALTERNATIVE AND CLOSED THE PT WITH THIS UNLOCKED SURFACE IN PLACE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEXGEN LEGCAY LCCK ARTICULAR SURFACE	KNEE PROSTHESIS	JWH	ZIMMER INC		60480681

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR