MAUDE MDR 3632237

MDR report key: 3632237
Report number: 1020279-2014-00101
Event key: 0
Event type: 3
Date of event: 2014-01-30
Date received: 2014-02-18
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: MRS. MELANIE TRAVIS
Address: 1450 BROOKS ROAD 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	BIOLOX	FEMORAL COMPONENT	SMITH & NEPHEW, INC.	LPF		76539155	11FT07486				R	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2014-02-18	0	1. H

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

N

Patient 1

N

Patient 1

IT IS UNKNOWN FROM THE INFORMATION PROVIDED IF THE OBSERVED METAL TRANSFER AND DEFORMATION ON THESE COMPONENTS WERE SUSTAINED DURING REMOVAL OF THE DEVICE OR WERE DUE TO IMPINGEMENT OF THE COMPONENTS IN VIVO. BONE INGROWTH WAS OBSERVED ON THE ACETABULAR CUP.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00889024408425	NA	Zimmer, Inc.	LPF	2016-07-13

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

MAUDE MDR 3632237

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

N

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#