FDA Adverse Event Injury Summary report: N

NEXGEN LEGACY LPS ARTICULAR SURFACE

MDR report key: 2130524 · Received June 14, 2011

Report

Report Number: 1822565-2011-01388
Event Type: Injury
Date Received: June 14, 2011
Report Date: May 16, 2011
Manufacturer: ZIMMER, INC.
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

Description of Event or Problem · 1

IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEXGEN LEGACY LPS ARTICULAR SURFACE		JWH	ZIMMER, INC.		60691055

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	CATALOG #00599603801, LOT #60934265\| LOT #60927223,\| CATALOG #00599601551, LOT #60908807\| NEXGEN STEMMED TIBIAL COMPONENT:\| NEXGEN ALL POLY PATELLA: CATALOG #00597206532,\| NEXGEN LPS FEMORAL COMPONENT:\| MANUFACTURED ZIMMER (B)(4)