TPLC - Total Product Life Cycle

• Device: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
• Regulation Description: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
• Product Code: JWH
• Regulation Number: 888.3560
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESCULAP
	SUBSTANTIALLY EQUIVALENT	10
BIOMET
	SUBSTANTIALLY EQUIVALENT	46
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	4
BIOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	2
CENTERPULSE ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONFORMIS, INC.
	SUBSTANTIALLY EQUIVALENT	11
DEPUY INTL., LTD.
	SUBSTANTIALLY EQUIVALENT	31
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	13
DJ ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
DOW
	SUBSTANTIALLY EQUIVALENT	12
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	12
ENCORE MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	9
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	6
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	16
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	8
HAYES
	SUBSTANTIALLY EQUIVALENT	2
IMPLEX
	SUBSTANTIALLY EQUIVALENT	15
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	2
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	8
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	7
JOINT MEDICAL PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT	2
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	5
KINAMED, INC.
	SUBSTANTIALLY EQUIVALENT	3
MATERIALISE N.V.
	SUBSTANTIALLY EQUIVALENT	5
OMNI
	SUBSTANTIALLY EQUIVALENT	8
ORTHO DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	7
ORTHOPEDIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
PLUS ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	6
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	25
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
STELKAST
	SUBSTANTIALLY EQUIVALENT	9
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	33
SULZER
	SUBSTANTIALLY EQUIVALENT	8
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	1
TORNIER
	SUBSTANTIALLY EQUIVALENT	3
U&I CORP.
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	17
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	2
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	32
	SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS	5

Device Problems
Implant, removal of	3471
No Information	2420
Loose	1745
Loss of or failure to bond	1083
Naturally worn	1062
Component(s), worn	1027
Unknown (for use when the device problem is not known)	857
Loose or intermittent connection	512
Explanted	448
No code available	416
Fracture	387
Other (for use when an appropriate device code cannot be identified)	283
Device remains implanted	281
Loss of osseointegration	235
Break	170
Malposition of device	146
Fitting problem	138
Detachment of device component	106
Migration of device or device component	103
Difficult to insert	79
Dislodged or dislocated	72
No Known Device Problem	68
Disassembly	53
Device, or device fragments remain in patient	51
Unstable	49
Dislocated	44
Component(s), broken	43
Tear, rip or hole in device packaging	38
Disengaged	37
Size incorrect for patient	35
Foreign material	28
Malfunction	22
Metal shedding debris	22
Component incompatible	21
Component missing	17
Noise	15
Slippage of device or device component	15
Pitted	14
User used incorrect product for intended use	11
Contamination during use	10
Mislabeled	9
Displacement	8
Device Issue	7
Packaging issue	7
Replace	7
Failure to Adhere or Bond	6
Noise, Audible	6
Incomplete or missing packaging	6
Device damaged prior to use	5
Device expiration issue	5
Foreign material present in device	5
Unsealed device packaging	4
Misapplication	4
Device markings issue	4
Patient-device incompatibility	4
Difficult to remove	4
Sticking	3
Seal, defective	3
Crack	3
Locking mechanism failure	3
Device, removal of (non-implant)	3
Incompatibility problem	3
Device operates differently than expected	3
Material fragmentation	3
Material discolored	3
Gradient increase	2
Material separation	2
Interlock(s), failure of	2
Positioning Issue	2
Couple, failure to	2
Reaction	2
Degraded	1
Failure to osseointegrate	1
Lens, repositioning of	1
Mechanical issue	1
Interference	1
Computer system security issue	1
Collapse	1
Disinfection, inadequate/improper	1
Device inoperable	1
Failure to align	1
Sterility	1
Abnormal	1
Cable, defective	1
Residue after decontamination	1
Cutoff point	1
Electro-magnetic interference (EMI)	1
Magnet failure	1
Misassembled	1
Delivered as unsterile product	1
Flaked	1
Rejection	1
Design/structure problem	1
Accessory incompatible	1
Manufacturing or shipping issue associated with device	1
Component(s), overheating of	1
Implant breakage or physical damage	1
Detachment of device or device component	1
High flux rate	1
Membrane leak(s)	1
Total Device Problems	15793

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	10	7	13	22	6	13	2
Class III	1	2	1	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Mar-02-2012
2	Biomet, Inc.	II	Jan-11-2012
3	Biomet, Inc.	II	Aug-04-2011
4	Biomet, Inc.	II	Apr-28-2011
5	Biomet, Inc.	II	Aug-10-2010
6	Biomet, Inc.	II	Nov-21-2008
7	Biomet, Inc.	II	Jul-25-2008
8	Biomet, Inc.	II	Jan-31-2008
9	Biomet, Inc.	II	Dec-05-2007
10	Biomet, Inc.	II	Nov-24-2007
11	Biomet, Inc.	II	Oct-31-2007
12	Conformis Inc	II	Aug-17-2012
13	DePuy Orthopaedics, Inc.	II	Aug-30-2011
14	Depuy Orthopaedics, Inc.	II	Aug-21-2009
15	Encore Medical, Lp	II	Dec-02-2011
16	Encore Medical, Lp	II	Aug-22-2010
17	Encore Medical, Lp	II	Apr-26-2010
18	Encore Medical, Lp	II	Apr-07-2010
19	Encore Medical, Lp	II	Feb-24-2010
20	Encore Medical, Lp	II	Jan-13-2010
21	Encore Medical, Lp	II	Sep-29-2008
22	Encore Medical, Lp	II	Aug-20-2008
23	Endotec, Inc.	II	May-20-2010
24	Exactech, Inc.	II	Mar-15-2013
25	Exactech, Inc.	II	Sep-04-2012
26	Exactech, Inc.	II	Aug-21-2012
27	Exactech, Inc.	II	Jul-24-2012
28	Exactech, Inc.	II	Feb-27-2007
29	Materialise USA LLC	II	May-14-2012
30	Omni Life Science	II	Sep-13-2012
31	Ortho Development Corporation	II	Apr-05-2010
32	Ortho Development Corporation	III	Sep-09-2009
33	Plus Orthopedics USA	II	Dec-08-2007
34	Plus Orthopedics USA	II	Dec-08-2007
35	Smith & Nephew Inc	II	Aug-23-2009
36	Stelkast Co	II	Nov-25-2008
37	Stelkast Co	III	Jan-23-2008
38	Stryker Howmedica Osteonics Corp.	II	Apr-05-2013
39	Stryker Howmedica Osteonics Corp.	II	Mar-16-2011
40	Stryker Howmedica Osteonics Corp.	II	Feb-11-2011
41	Stryker Howmedica Osteonics Corp.	II	Oct-06-2010
42	Stryker Howmedica Osteonics Corp.	II	Aug-31-2010
43	Stryker Howmedica Osteonics Corp.	II	Mar-16-2010
44	Stryker Howmedica Osteonics Corp.	II	Mar-02-2010
45	Stryker Howmedica Osteonics Corp.	II	Feb-19-2010
46	Stryker Howmedica Osteonics Corp.	II	Feb-01-2010
47	Stryker Howmedica Osteonics Corp.	II	Dec-01-2009
48	Stryker Howmedica Osteonics Corp.	II	Jul-23-2009
49	Stryker Howmedica Osteonics Corp.	II	Jul-15-2009
50	Stryker Howmedica Osteonics Corp.	II	Jul-07-2009
51	Stryker Howmedica Osteonics Corp.	II	Mar-03-2009
52	Stryker Howmedica Osteonics Corp.	II	Jan-26-2009
53	Stryker Howmedica Osteonics Corp.	II	Sep-16-2008
54	Stryker Howmedica Osteonics Corp.	III	Jul-16-2008
55	Stryker Howmedica Osteonics Corp.	II	Dec-11-2007
56	Stryker Howmedica Osteonics Corp.	II	Sep-25-2007
57	Stryker Howmedica Osteonics Corp.	III	Sep-21-2007
58	Stryker Howmedica Osteonics Corp.	II	Feb-08-2007
59	Wright Medical Technology Inc	II	May-21-2010
60	Wright Medical Technology Inc	II	Mar-31-2010
61	Zimmer Inc.	II	May-14-2012
62	Zimmer Inc.	II	Jan-25-2012
63	Zimmer Inc.	II	Dec-02-2010
64	Zimmer Inc.	II	Oct-21-2010
65	Zimmer Inc.	II	Sep-20-2010
66	Zimmer Inc.	II	Sep-13-2010
67	Zimmer Inc.	II	Mar-10-2010
68	Zimmer Inc.	II	Mar-02-2010
69	Zimmer Inc.	II	Dec-14-2009
70	Zimmer Inc.	II	Nov-13-2009
71	Zimmer Inc.	II	Jun-30-2009
72	Zimmer Inc.	II	Jun-26-2009
73	Zimmer Inc.	II	Jan-09-2009
74	Zimmer Inc.	II	Mar-28-2007
75	Zimmer, Inc.	II	Dec-18-2012
76	Zimmer, Inc.	II	Nov-26-2012
77	Zimmer, Inc.	II	Sep-28-2012