FDA Adverse Event Injury Summary report: N

NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE - POSTERIOR STABILIZED ARTICULAR SURFA

MDR report key: 908733 · Received September 7, 2007

Report

Report Number: 1822565-2007-00292
Event Type: Injury
Date Received: September 7, 2007
Date of Event: July 31, 2007
Report Date: August 3, 2007
Manufacturer: ZIMMER, INC.
Product Code: JWH
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EXHIBITS FRACTURE DAMAGE AT THE BASE OF THE SPINE (SPINE FRAGMENT NOT RECEIVED). BACKSIDE SURFACE SHOWS VISIBLE GOUGE MARKS AND STRIATIONS, AND THE ARTICULATING SURFACES EXHIBIT SLIGHT WEAR DAMAGE. X-RAYS ARE NOT AVAILABLE FOR REVIEW. IT IS LIKELY THE SPINE FRACTURED DUE TO ABNORMAL ANTERIOR-POSTERIOR ARTICULATION AND MEDIAL-LATERAL ROTATION OF THE FEMORAL COMPONENT AND FATIGUE, BUT THE CAUSE COULD NOT BE DEFINITIVELY DETERMINED DUE TO INSUFFICIENT INFORMATION. THE MAJORITY OF ENGRAVINGS ON THE INFERIOR SIDE HAVE BEEN WORK AWAY; THEREFORE, THE LOT NUMBER IS UNKNOWN AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. SCANNING ELECTRON MICROSCOPE EXAMINATION OF POST FRACTURE SURFACE SHOWED STRIATIONS INDICATING FRACTURE OCCURRED BY REPEATED LOADING. FATIGUE CRACK APPEARS TO HAVE PROPAGATED FROM THE ANTERIOR TO POSTERIOR SIDE. ENERGY DISPERSIVE SPECTROSCOPY ANALYSIS OF THE INSERT MATERIAL SHOWED A CARBON ( C ) PEAK IN THE SPECTRUM TYPICAL OF A UHMWPE.

Description of Event or Problem · 1

IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2003. POST-OP, THE SPINE FRACTURED ON THE POLY. THE DEVICE WAS REVISED IN 2007. EXACT IMPLANT DATE IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE - POSTERIOR STABILIZED ARTICULAR SURFA	KNEE PROSTHESIS	JWH	ZIMMER, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Hospitalization\| R