MAUDE MDR 3240224

MDR report key: 3240224
Report number: 8010764-2013-00034
Event key: 0
Event type: 3
Date of event: 2013-07-18
Date received: 2013-07-22
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: MR PHILLIP EMMERT
Address: 1450 E. BROOKS RD MEMPHIS TN 38116 US
Phone: 901-901-9013
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	FORTE	R3 32MM ID US CRMC LINER 48	SMITH&NEPHEW -GERMANY	LPF		71338948	09BT29146				*	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2013-07-22	0	1. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN. IMPLANTED IN 2009.

N

Patient 1

.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P820024S016	LPF	PROSTHESIS, HIP, HEMI-FEMORAL, METAL	Depuy, Inc.	1991-12-04
PMA	P820024S015	LPF	PROSTHESIS, HIP, HEMI-FEMORAL, METAL	Depuy, Inc.	1991-04-02
PMA	P820024S013	LPF	PROSTHESIS, HIP, HEMI-FEMORAL, METAL	Depuy, Inc.	1990-12-05
PMA	P820024S014	LPF	PROSTHESIS, HIP, HEMI-FEMORAL, METAL	Depuy, Inc.	1990-08-09
PMA	P820024S012	LPF	PROSTHESIS, HIP, HEMI-FEMORAL, METAL	Depuy, Inc.	1988-07-19