TPLC - Total Product Life Cycle

Device	prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Regulation Description	Hip joint metal/polymer constrained cemented or uncemented prosthesis.
Product Code	KWZ
Regulation Number	888.3310
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOMET
	SUBSTANTIALLY EQUIVALENT	4
CENTERPULSE ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	4
ENCORE MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	2
JOINT MEDICAL PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
OSTEOIMPLANT TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	5
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	4
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems
Implant, removal of	90
Dislodged or dislocated	89
Dislocated	62
No Information	44
Disassembly	24
Fracture	19
Unknown (for use when the device problem is not known)	14
Malfunction	10
Break	10
Difficult to insert	8
Fitting problem	8
No code available	8
Other (for use when an appropriate device code cannot be identified)	7
Component(s), worn	7
Loose	5
Naturally worn	5
Explanted	4
Loose or intermittent connection	3
Detachment of device component	3
Migration of device or device component	2
Delivered as unsterile product	1
Unsealed device packaging	1
Device remains implanted	1
Difficult to remove	1
Foreign material	1
Bent	1
Compatibility	1
Component(s), broken	1
Component incompatible	1
Disengaged	1
Component missing	1
Malposition of device	1
Detachment of device or device component	1
Device Issue	1
Loss of osseointegration	1
Total Device Problems	437