TPLC - Total Product Life Cycle

Device	prosthesis, hip, femoral, resurfacing
Regulation Description	Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
Product Code	KXA
Regulation Number	888.3400
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOMET
	SUBSTANTIALLY EQUIVALENT	4
BIOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
No Information	947
Metal shedding debris	175
Dislodged or dislocated	40
Noise, Audible	31
No Known Device Problem	28
No code available	26
Loss of or failure to bond	25
Implant, removal of	22
Unknown (for use when the device problem is not known)	20
Loss of osseointegration	19
Loose or intermittent connection	10
Malposition of device	7
Break	7
Fracture	7
Loose	5
Other (for use when an appropriate device code cannot be identified)	3
Component(s), broken	2
Disassembly	2
Explanted	1
Defective item	1
Naturally worn	1
Not Applicable	1
Unsealed device packaging	1
User used incorrect product for intended use	1
Failure to osseointegrate	1
Dislocated	1
Corrosion	1
Ambient noise issue	1
Malfunction	1
Component(s), worn	1
Total Device Problems	1388