TPLC - Total Product Life Cycle

• Device: bone cement
• Regulation Description: Polymethylmethacrylate (PMMA) bone cement.
• Product Code: LOD
• Regulation Number: 888.3027
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIOMET
	SUBSTANTIALLY EQUIVALENT	7
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	9
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	5
IMMEDICA INC.
	SUBSTANTIALLY EQUIVALENT	1
KULZER
	SUBSTANTIALLY EQUIVALENT	5
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	5

Device Problems
Loss of or failure to bond	454
Loose	126
Implant, removal of	103
No Information	33
Unknown (for use when the device problem is not known)	31
Other (for use when an appropriate device code cannot be identified)	25
Malfunction	23
No code available	15
Loose or intermittent connection	10
Tear, rip or hole in device packaging	8
Fracture	8
Break	6
Loss of osseointegration	6
Leak	4
Delivered as unsterile product	4
Reaction	4
Unsealed device packaging	4
Foreign material	4
Incomplete or missing packaging	3
Component(s), worn	3
Failure to Adhere or Bond	3
Clumping in device or device ingredient	3
Absorption	2
Coagulation in device or device ingredient	2
Chemical issue	2
Device remains implanted	2
Device expiration issue	2
Explode	1
Ignited	1
Particulates	1
Crack	1
Disassembly	1
Component missing	1
Dislodged or dislocated	1
Naturally worn	1
Packaging issue	1
Sterility	1
Migration of device or device component	1
Device Issue	1
No Known Device Problem	1
Difficult to insert	1
Disengaged	1
Improper or incorrect procedure or method	1
Defective component	1
Fibrosis	1
Total Device Problems	908

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