FDA Adverse Event Injury Summary report: N

NEXGEN CR-FLEX FEMORAL COMPONENT

MDR report key: 2860463 · Received December 5, 2012

Report

Report Number: 1822565-2012-02476
Event Type: Injury
Date Received: December 5, 2012
Report Date: November 6, 2012
Manufacturer: ZIMMER, INC.
Product Code: JWH
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

REVIEW OF SURGICAL REPORTS PROVIDED INDICATES SURGICAL TECHNIQUE WAS FOLLOWED. NO X-RAYS WERE RECEIVED, SO NO CHECK COULD BE MADE FOR CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL OR TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 EXPERIENCED PAIN, SWELLING AND BONE DETERIORATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEXGEN CR-FLEX FEMORAL COMPONENT		JWH	ZIMMER, INC.		60881381

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	ZIMMER (B)(4)\| THE FOLLOWING COMPONENTS WERE MANUFACTURED AT\| NEXGEN TAPER STEM PLUG, CATALOG #00596009900\| LOT #60931980\| NEXGEN ALL POLY PATELLA, CATALOG #00597206538\| NEXGEN CR ARTICULAR SURFACE, CATALOG #90597004010\| LOT #60927985\| NEXGEN STEMMED TIBIAL COMPONENT, CATALOG\| LOT #60825409\| #00598004701, LOT #60914710