TPLC - Total Product Life Cycle

• Device: prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
• Product Code: LPH
• Regulation Number: 888.3358
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOCORE9, LLC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	3
BIOMET MANUFACTUTING CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	7
CARDO MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
CONFORMIS, INC.
	SUBSTANTIALLY EQUIVALENT	4
CONSENSUS ORTHOPEDICS, INC
	SUBSTANTIALLY EQUIVALENT	3
CONSENSUS ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
CORENTEC CO., LTD
	SUBSTANTIALLY EQUIVALENT	8
CORENTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
CORENTEC CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DEPUY INTERNATIONAL, LTD
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	4
DEPUY ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
DEPUY ORTHOPAEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ENCORE MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
ENCORE MEDICAL, L.P.
	SUBSTANTIALLY EQUIVALENT	6
EXACTECH, INC
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	8
EXCERA ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
HOWMEDICA OSTEONICS
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP
	SUBSTANTIALLY EQUIVALENT	3
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. (AKA STRYKER ORTHOPAEDICS)
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. A.K.A. STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. AKA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	3
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
ICONACY ORTHOPEDIC IMPLANTS, LLC
	SUBSTANTIALLY EQUIVALENT	5
LIMACORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	7
MAKO SURGICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	3
MEDACTA INTERNATIONAL S .A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC ADVANCED ENERGY
	SUBSTANTIALLY EQUIVALENT	1
MERIL HEALTHCARE PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	2
MICROPORT ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS INC
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	3
MICROPORT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NOVOSOURCE INC
	SUBSTANTIALLY EQUIVALENT	1
OMNI LIFE SCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	3
OMNILIFE SCIENCE INC.
	SUBSTANTIALLY EQUIVALENT	2
OMNLIFE SCIENCE
	SUBSTANTIALLY EQUIVALENT	3
ONKOS SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
ONKOS SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	2
ORTHO DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	3
ORTHO DEVELOPMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
PIPELINE BIOTECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	1
PIPELINE ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	2
PRECISION CASTING SOLUTION, LLC
	SUBSTANTIALLY EQUIVALENT	1
RENOVIS SURGICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
RENOVIS SURGICAL TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGNATURE ORTHOPAEDICS, PTY, LTD
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	17
STELKAST, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	4
TGM MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TGM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
THE PROGRESSIVE ORTHOPAEDIC COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	2
THECKEN COMPANIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
THEKEN COMPANIES
	SUBSTANTIALLY EQUIVALENT	1
THEKEN COMPANIES, LLC
	SUBSTANTIALLY EQUIVALENT	3
TOTAL JOINT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
TOTAL JOINT OTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
UNITED ORTHOPEDIC CORP.
	SUBSTANTIALLY EQUIVALENT	2
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	10
WALDEMAR LINK GMBH & CO KG
	SUBSTANTIALLY EQUIVALENT	1
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	9

MDR Year	MDR Reports	MDR Events
2014	5146	5146
2015	5805	5805
2016	4885	4885
2017	5307	5307
2018	5929	5929
2019	7118	7118
2020	5425	5425
2021	5983	5983
2022	5224	5224
2023	5378	5415
2024	3810	3810

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	16734	16756
Insufficient Information	12016	12016
Device Dislodged or Dislocated	10195	10210
Appropriate Term/Code Not Available	3614	3614
Naturally Worn	3125	3125
Loss of Osseointegration	2984	2984
Fracture	2852	2852
Corroded	2131	2131
Osseointegration Problem	1888	1888
Material Erosion	1415	1415
Malposition of Device	1380	1380
Degraded	1253	1253
Break	987	987
Noise, Audible	941	941
Disassembly	867	867
Difficult to Insert	830	830
Unstable	812	812
Loose or Intermittent Connection	747	747
Migration	722	722
Metal Shedding Debris	679	679
Migration or Expulsion of Device	675	675
Detachment of Device or Device Component	587	587
Use of Device Problem	556	556
Loosening of Implant Not Related to Bone-Ingrowth	414	414
Material Deformation	406	406
Biocompatibility	362	362
Material Integrity Problem	358	358
Device Contaminated During Manufacture or Shipping	357	357
Packaging Problem	325	325
Loss of or Failure to Bond	322	322
Mechanical Problem	309	309
Device Operates Differently Than Expected	306	306
Device Slipped	299	299
Positioning Problem	260	260
Difficult to Remove	240	240
Device-Device Incompatibility	230	230
Inadequacy of Device Shape and/or Size	180	180
Manufacturing, Packaging or Shipping Problem	176	176
Fitting Problem	164	164
Unintended Movement	158	158
Tear, Rip or Hole in Device Packaging	139	139
Separation Failure	125	125
Material Disintegration	122	122
Failure to Osseointegrate	121	121
Positioning Failure	120	120
Patient Device Interaction Problem	117	117
Patient-Device Incompatibility	116	116
Detachment Of Device Component	114	114
No Apparent Adverse Event	105	105
Failure To Adhere Or Bond	105	105

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	18131	18131
No Code Available	10730	10730
Unspecified Infection	8986	9008
Joint Dislocation	6797	6812
No Information	6453	6453
Injury	5122	5122
Discomfort	3774	3774
Foreign Body Reaction	3732	3732
Inadequate Osseointegration	3379	3379
Inflammation	3095	3095
Insufficient Information	2906	2906
Bone Fracture(s)	2557	2557
Tissue Damage	2341	2341
Osteolysis	2166	2166
Ambulation Difficulties	2154	2154
Metal Related Pathology	1952	1952
Reaction	1913	1913
Joint Laxity	1815	1815
Test Result	1675	1675
Host-Tissue Reaction	1634	1634
No Clinical Signs, Symptoms or Conditions	1534	1534
Limited Mobility Of The Implanted Joint	1534	1534
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1525	1525
Loss of Range of Motion	1480	1480
No Known Impact Or Consequence To Patient	1475	1475
Fall	1431	1431
Failure of Implant	1185	1185
No Consequences Or Impact To Patient	1184	1184
Hypersensitivity/Allergic reaction	1123	1123
Not Applicable	1081	1081
Necrosis	917	917
Swelling	738	738
Swelling/ Edema	738	738
Unspecified Tissue Injury	734	734
Toxicity	619	619
Limb Fracture	567	567
Scar Tissue	537	537
Hematoma	527	527
Distress	512	512
Synovitis	501	501
Ossification	472	472
Adhesion(s)	471	471
Edema	416	416
Local Reaction	398	398
No Patient Involvement	395	395
Weakness	364	364
Fatigue	354	354
Cyst(s)	330	330
Muscle/Tendon Damage	324	324
Physical Asymmetry	286	286

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Mar-23-2023
2	Biomet, Inc.	II	Dec-17-2020
3	Biomet, Inc.	II	Aug-29-2015
4	Biomet, Inc.	III	Jun-11-2015
5	Biomet, Inc.	II	Feb-17-2015
6	Biomet, Inc.	II	Jun-05-2013
7	Biomet, Inc.	II	Jun-08-2011
8	Biomet, Inc.	II	May-26-2010
9	CORENTEC CO., LTD	II	Mar-13-2017
10	Conformis, Inc.	II	Nov-20-2020
11	Conformis, Inc.	II	Oct-08-2019
12	Conformis, Inc.	II	Jun-13-2019
13	Conformis, Inc.	II	Jan-12-2019
14	DePuy Orthopaedics, Inc.	II	May-22-2013
15	DePuy Orthopaedics, Inc.	II	Dec-20-2012
16	DePuy Orthopaedics, Inc.	II	Dec-19-2012
17	DePuy Orthopaedics, Inc.	II	Aug-17-2012
18	Djo Surgical	II	Mar-04-2014
19	Encore Medical, LP	II	Oct-12-2023
20	Encore Medical, LP	II	Oct-21-2022
21	Encore Medical, LP	II	Oct-20-2020
22	Encore Medical, LP	II	May-08-2020
23	Encore Medical, LP	II	Apr-10-2020
24	Encore Medical, Lp	II	Jul-19-2016
25	Exactech, Inc.	II	Jan-18-2024
26	Exactech, Inc.	II	Sep-09-2022
27	Exactech, Inc.	II	Jul-22-2021
28	Exactech, Inc.	II	Jan-17-2017
29	Exactech, Inc.	II	Feb-03-2014
30	Howmedica Osteonics Corp.	II	Apr-25-2024
31	Howmedica Osteonics Corp.	II	Feb-16-2022
32	Howmedica Osteonics Corp.	II	May-07-2020
33	Howmedica Osteonics Corp.	II	Nov-22-2019
34	Howmedica Osteonics Corp.	II	Mar-09-2018
35	Limacorporate S.p.A	II	Oct-21-2021
36	OMNIlife science Inc.	II	Oct-21-2019
37	OMNIlife science Inc.	II	Sep-05-2019
38	OMNIlife science Inc.	II	Jul-25-2018
39	OmniLife Science	II	Nov-16-2021
40	Omnilife Science Inc.	II	Aug-21-2015
41	Orthopedic Alliance LLC	II	May-24-2013
42	Signal Medical Corporation	II	Oct-22-2014
43	Smith & Nephew Inc	II	Dec-26-2013
44	Smith & Nephew Inc	II	Apr-21-2009
45	Smith & Nephew, Inc.	II	Mar-20-2019
46	Stryker Howmedica Osteonics Corp.	II	Jul-25-2016
47	Stryker Howmedica Osteonics Corp.	II	Nov-10-2015
48	Stryker Howmedica Osteonics Corp.	II	Sep-23-2015
49	Stryker Howmedica Osteonics Corp.	II	May-19-2015
50	Stryker Howmedica Osteonics Corp.	II	Mar-02-2010
51	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Sep-26-2023
52	Wright Medical Technology Inc	II	Oct-31-2012
53	Zimmer Biomet, Inc.	II	Oct-06-2020
54	Zimmer Biomet, Inc.	II	Nov-22-2019
55	Zimmer Biomet, Inc.	II	Nov-07-2019
56	Zimmer Biomet, Inc.	II	Jul-05-2018
57	Zimmer Biomet, Inc.	II	Apr-27-2018
58	Zimmer Biomet, Inc.	II	Mar-14-2018
59	Zimmer Biomet, Inc.	II	Mar-14-2018
60	Zimmer Biomet, Inc.	II	Mar-09-2018
61	Zimmer Biomet, Inc.	II	Feb-26-2018
62	Zimmer Biomet, Inc.	II	Jan-04-2018
63	Zimmer Biomet, Inc.	II	Mar-20-2017
64	Zimmer Biomet, Inc.	II	Jan-13-2017
65	Zimmer Biomet, Inc.	II	Mar-04-2016
66	Zimmer Biomet, Inc.	II	Feb-22-2016
67	Zimmer Gmbh	II	Feb-20-2015
68	Zimmer Inc.	II	Jun-26-2015
69	Zimmer Inc.	II	Dec-01-2011
70	Zimmer Inc.	II	Oct-14-2010
71	Zimmer Inc.	II	Aug-26-2010
72	Zimmer Inc.	II	Aug-12-2010
73	Zimmer Inc.	II	Nov-13-2009
74	Zimmer Inc.	II	Jul-27-2009
75	Zimmer Manufacturing B.V.	II	May-16-2016
76	Zimmer Manufacturing B.V.	II	Mar-12-2016
77	Zimmer Manufacturing B.V.	II	Dec-24-2014
78	Zimmer Manufacturing B.V.	II	Dec-17-2014
79	Zimmer Trabecular Metal Technology, Inc.	II	Jun-10-2016
80	Zimmer, Inc.	II	Mar-29-2023
81	Zimmer, Inc.	II	Jul-10-2014
82	Zimmer, Inc.	II	Jun-20-2014
83	Zimmer, Inc.	II	Apr-24-2014
84	Zimmer, Inc.	II	Feb-20-2014
85	Zimmer, Inc.	II	Oct-25-2013
86	Zimmer, Inc.	II	Feb-04-2013
87	Zimmer, Inc.	II	Nov-21-2012