MAUDE MDR 285227

MDR report key: 285227
Report number: 285227
Event key: 0
Event type: 3
Date of event: 2000-04-27
Date received: 2000-06-29
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 2
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Report source: U
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	TOTAL KNEE	INSERT	WRIGHT MEDICAL TECHNOLOGY, INC.	KRP	1870-3212	*	112ME09590			Y		N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2000-06-29	0	1. R

Event Narratives#

D

Patient 1

SURGICAL PROCEDURE. RIGHT TOTAL KNEE WITH POLYETHYLENE WEAR. PAINFUL RIGHT KNEE.