TPLC - Total Product Life Cycle

• Device: prosthesis, hip, femoral component, cemented, metal
• Regulation Description: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
• Product Code: JDG
• Regulation Number: 888.3360
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIOMET
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	2
CARBOMEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	4
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	4
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
DOW
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	2
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOINT MEDICAL PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
ORTHOPEDIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
STELKAST
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1

Device Problems
Implant, removal of	63
Dislodged or dislocated	25
Dislocated	25
Loose	24
No Information	14
Unknown (for use when the device problem is not known)	8
Other (for use when an appropriate device code cannot be identified)	7
Fracture	5
Loss of osseointegration	5
Device remains implanted	5
Loss of or failure to bond	4
Break	2
Component(s), broken	2
Component(s), worn	2
No code available	2
Malposition of device	1
Disassembly	1
Device expiration issue	1
Total Device Problems	196

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	1	0	0	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Howmedica Osteonics Corp.	II	Nov-23-2009