TPLC - Total Product Life Cycle

• Device: prosthesis, elbow, constrained, cemented
• Regulation Description: Elbow joint metal/polymer constrained cemented prosthesis.
• Product Code: JDC
• Regulation Number: 888.3150
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET
	SUBSTANTIALLY EQUIVALENT	9
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
TORNIER
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	5
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1

Device Problems
Explanted	79
Component(s), worn	43
Implant, removal of	41
Loose	40
Fracture	23
Break	22
Disengaged	14
Disassembly	11
Device inoperable	9
Device packaging compromised	9
Naturally worn	8
No Information	8
No code available	8
Unknown (for use when the device problem is not known)	7
Device remains implanted	7
Loose or intermittent connection	6
Dislocated	5
Component incompatible	3
Fitting problem	3
Other (for use when an appropriate device code cannot be identified)	2
Slippage of device or device component	2
Dislodged or dislocated	2
Foreign material	2
Detachment of device component	1
Replace	1
Material rigid or stiff	1
Migration of device or device component	1
Unintended system motion	1
Material puncture	1
Component missing	1
Loss of osseointegration	1
Total Device Problems	362

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	1	1	0	1	2	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Feb-21-2012
2	Biomet, Inc.	II	Jun-24-2011
3	Biomet, Inc.	II	Oct-03-2008
4	Zimmer Inc.	II	Apr-02-2009
5	Zimmer, Inc.	II	Dec-18-2012