TPLC - Total Product Life Cycle

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Device	prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Product Code	KWY
Regulation Number	888.3390
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORENTEC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DEPUY FRANCE S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	1
G21, S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
HERAEUS MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
IMPLANTCAST, GMBH
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTS INTERNATIONAL, LTD
	SUBSTANTIALLY EQUIVALENT	1
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	1
OMNI LIFE SCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
OMNLIFE SCIENCE
	SUBSTANTIALLY EQUIVALENT	1
ONKOS SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RENOVIS SURGICAL TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SURGTECH, INC.,
	SUBSTANTIALLY EQUIVALENT	1
TGM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
THEKEN COMPANIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
TOTAL JOINT ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	2555	2555
Adverse Event Without Identified Device or Use Problem	2014	2014
Device Dislodged or Dislocated	1613	1613
Naturally Worn	726	726
Appropriate Term/Code Not Available	658	658
Fracture	297	297
Loss of Osseointegration	271	271
Corroded	186	186
Noise, Audible	162	162
Metal Shedding Debris	135	135
Difficult to Insert	129	129
Material Erosion	102	102
Migration	92	92
Break	92	92
Migration or Expulsion of Device	85	85
Loose or Intermittent Connection	80	80
Loss of or Failure to Bond	69	69
Malposition of Device	68	68
Nonstandard Device	61	61
Unstable	49	49
Disassembly	49	49
Loosening of Implant Not Related to Bone-Ingrowth	45	45
Biocompatibility	43	43
Detachment of Device or Device Component	43	43
Degraded	43	43
Osseointegration Problem	39	39
Fitting Problem	38	38
Device Contamination with Chemical or Other Material	36	36
Use of Device Problem	32	32
Unintended Movement	28	28
Device Operates Differently Than Expected	27	27
Device Slipped	26	26
Material Disintegration	26	26
Device Contaminated During Manufacture or Shipping	23	23
Patient-Device Incompatibility	23	23
Delivered as Unsterile Product	20	20
Difficult to Remove	20	20
Material Integrity Problem	20	20
Patient Device Interaction Problem	19	19
Packaging Problem	19	19
Inadequacy of Device Shape and/or Size	18	18
Detachment Of Device Component	18	18
Mechanical Problem	17	17
Device-Device Incompatibility	13	13
Positioning Failure	13	13
Positioning Problem	12	12
Separation Failure	12	12
No Apparent Adverse Event	11	11
Failure to Osseointegrate	10	10
Compatibility Problem	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	3299	3300
No Code Available	3025	3028
No Information	1213	1213
Joint Dislocation	1117	1118
Unspecified Infection	1067	1068
Foreign Body Reaction	626	626
Test Result	552	552
Injury	471	471
Discomfort	466	466
Osteolysis	422	422
Tissue Damage	380	380
Bone Fracture(s)	324	324
Host-Tissue Reaction	312	312
Not Applicable	307	307
Inflammation	304	304
Limited Mobility Of The Implanted Joint	248	248
No Consequences Or Impact To Patient	210	210
Reaction	196	196
Loss of Range of Motion	194	194
Hypersensitivity/Allergic reaction	193	193
Ambulation Difficulties	170	170
No Known Impact Or Consequence To Patient	165	165
Inadequate Osseointegration	151	151
Failure of Implant	137	137
No Clinical Signs, Symptoms or Conditions	133	133
Toxicity	127	127
Insufficient Information	116	116
Fall	113	113
Necrosis	108	108
Swelling	103	103
Edema	94	94
Hematoma	93	93
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	84	84
Weakness	69	69
Thrombosis	65	65
Distress	58	58
Joint Laxity	55	55
Metal Related Pathology	53	53
Cyst(s)	53	53
Pulmonary Embolism	50	50
No Patient Involvement	50	50
Adhesion(s)	45	45
Synovitis	41	41
Ossification	39	39
Fatigue	39	39
Scar Tissue	37	37
Hip Fracture	36	36
Impaired Healing	35	35
Joint Disorder	30	30
Death	29	29

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Apr-03-2020
2	Exactech, Inc.	II	Jun-28-2024
3	Omni Life Science	II	Sep-10-2009
4	Ortho Development Corporation	II	Aug-17-2014
5	Ortho Development Corporation	II	Nov-03-2010
6	Ortho Development Corporation	II	Oct-28-2009
7	Orthopedic Alliance LLC	II	May-24-2013
8	Smith & Nephew, Inc.	II	Nov-03-2016
9	Zimmer Biomet, Inc.	II	Nov-22-2019
10	Zimmer Biomet, Inc.	II	Nov-07-2018
11	Zimmer Biomet, Inc.	II	Mar-14-2018
12	Zimmer Biomet, Inc.	II	Feb-15-2018
13	Zimmer Biomet, Inc.	II	Feb-22-2016
14	Zimmer Manufacturing B.V.	II	Mar-12-2016
15	Zimmer, Inc.	II	Feb-20-2014
16	Zimmer, Inc.	II	Oct-25-2013
17	Zimmer, Inc.	II	Nov-20-2012