FDA Adverse Event Malfunction Summary report: N

NEXGEN MIS TRABECULAR METAL TIBIAL TRAY

MDR report key: 1900358 · Received October 26, 2010

Report

Report Number: 1822565-2010-01011
Event Type: Malfunction
Date Received: October 26, 2010
Date of Event: August 16, 2010
Report Date: October 5, 2010
Manufacturer: ZIMMER, INC.
Product Code: JWH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: X-RAYS WERE PROVIDED. INSPECTION OF THE X-RAYS APPEARS TO CONFIRM THE MINIMAL RADIOLUCENT LINES DEVELOPING UNDER THE TIBIAL COMPONENT. THIS COULD LEAD TO THE LOOSENING SUGGESTED BY THE SURGEON. PAIN AND SWELLING CAN BE INFLUENCED BY MANY FACTORS, HOWEVER. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO, PT WEIGHT, PT ACTIVITY, BONE QUALITY, IMPLANT SIZE, SURGICAL TECHNIQUE, AND REHABILITATION PROGRAM. WITHOUT ADDITIONAL INFO, A DEFINITIVE CAUSE CANNOT BE DETERMINED AT THIS TIME. EVAL CODES: NO PRODUCT WAS RETURNED. 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 THE PT'S X-RAYS SHOW LUCENT LINES DEVELOPING UNDER TIBIAL BASE PLATE ON THE MEDIAL AND LATERAL EDGES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEXGEN MIS TRABECULAR METAL TIBIAL TRAY	KNEE PROSTHESIS	JWH	ZIMMER, INC.		61247069

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR