TPLC - Total Product Life Cycle

• Device: prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
• Product Code: LZO
• Regulation Number: 888.3353
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESCULAP IMPLANT SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP IMPLANT SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	3
AESCULAP IMPLANTS SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ASTON MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
B-ONE ORTHO CORP.
	SUBSTANTIALLY EQUIVALENT	3
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
BIOMET UK LTD.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	3
CARDO MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
CORENTEC CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CORENTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN LTD.
	SUBSTANTIALLY EQUIVALENT	1
CORIN MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
CORIN U.S.A.
	SUBSTANTIALLY EQUIVALENT	5
CORIN USA
	SUBSTANTIALLY EQUIVALENT	14
CORIN USA LIMITED
	SUBSTANTIALLY EQUIVALENT	6
DEPUY (IRELAND)
	SUBSTANTIALLY EQUIVALENT	1
DEPUY FRANCE S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	5
DEPUY ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
DEPUY ORTHOPAEDICS INC.
	SUBSTANTIALLY EQUIVALENT	2
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
EXACTECH, INC
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	9
GLOBAL MANUFACTURING TECHNOLOGY
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
ICONACY ORTHOPEDIC IMPLANTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
IMPLANTCAST GMBH
	SUBSTANTIALLY EQUIVALENT	4
IMPLANTCAST, GMBH
	SUBSTANTIALLY EQUIVALENT	3
KYOCERA MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
LIMACORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	8
MAXX ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	1
MAXX ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL
	SUBSTANTIALLY EQUIVALENT	10
MEDACTA INTERNATIONAL S .A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	2
MEDACTA INTERNATIONAL SA
	SUBSTANTIALLY EQUIVALENT	17
MEDACTA INTERNATIONAL, SA
	SUBSTANTIALLY EQUIVALENT	4
MERETE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
MERIL HEALTHCARE PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS INC.
	SUBSTANTIALLY EQUIVALENT	8
MICROPORT ORTHOPEDICS INC. (MPO)
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
OMNI LIFE SCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	2
OMNILIFE SCIENCE
	SUBSTANTIALLY EQUIVALENT	3
OMNILIFE SCIENCE INC.
	SUBSTANTIALLY EQUIVALENT	2
ORCHARD MEDICAL DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	1
OTIS BIOTECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
RESPONSIVE ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SERF
	SUBSTANTIALLY EQUIVALENT	4
SIGNATURE ORTHOPAEDICS PTY LTD.
	SUBSTANTIALLY EQUIVALENT	5
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	14
TGM MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOTAL JOINT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
TOTAL JOINT OTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
UNITED ORTHOPEDIC CORP.
	SUBSTANTIALLY EQUIVALENT	2
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	8
WALDEMAR LINK GMBH & CO.KG
	SUBSTANTIALLY EQUIVALENT	1
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	7
XERXES ARTHOPEDIX LLC
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	10
ZIMMER, INC
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	6

MDR Year	MDR Reports	MDR Events
2014	1467	1467
2015	1343	1343
2016	1727	1727
2017	2159	2159
2018	3128	3128
2019	3075	3075
2020	1957	1957
2021	2200	2200
2022	1985	1985
2023	2073	2098
2024	1095	1095

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4889	4914
Insufficient Information	4755	4755
Device Dislodged or Dislocated	4395	4395
Appropriate Term/Code Not Available	1679	1679
Fracture	1417	1417
Naturally Worn	632	632
Break	627	627
Loose or Intermittent Connection	570	570
Osseointegration Problem	458	458
Corroded	357	357
Material Erosion	355	355
Unstable	348	348
Noise, Audible	303	303
Loosening of Implant Not Related to Bone-Ingrowth	279	279
Loss of Osseointegration	222	222
Migration	221	221
Migration or Expulsion of Device	218	218
Device Slipped	191	191
Metal Shedding Debris	171	171
Malposition of Device	161	161
Difficult to Insert	160	160
Inadequacy of Device Shape and/or Size	153	153
Patient Device Interaction Problem	118	118
Tear, Rip or Hole in Device Packaging	115	115
Device Operates Differently Than Expected	112	112
Device Appears to Trigger Rejection	112	112
Detachment of Device or Device Component	106	106
Packaging Problem	106	106
Patient-Device Incompatibility	98	98
Degraded	88	88
Material Integrity Problem	85	85
Mechanical Problem	83	83
Positioning Problem	79	79
Manufacturing, Packaging or Shipping Problem	76	76
Failure To Adhere Or Bond	75	75
Failure to Osseointegrate	72	72
No Apparent Adverse Event	69	69
Fitting Problem	67	67
Unintended Movement	66	66
Crack	63	63
Difficult to Remove	62	62
Use of Device Problem	56	56
Material Deformation	56	56
Improper or Incorrect Procedure or Method	53	53
Nonstandard Device	51	51
Device Contaminated During Manufacture or Shipping	51	51
Scratched Material	48	48
Loss of or Failure to Bond	46	46
Biocompatibility	45	45
Device-Device Incompatibility	44	44
Material Disintegration	38	38
Device Markings/Labelling Problem	37	37
Device Contamination with Chemical or Other Material	37	37
Material Fragmentation	35	35
Disassembly	29	29
Material Separation	28	28
Positioning Failure	26	26
Mechanical Jam	26	26
Microbial Contamination of Device	25	25
Detachment Of Device Component	23	23
Off-Label Use	22	22
Difficult To Position	20	20
Device Damaged Prior to Use	20	20
Separation Failure	20	20
Inaccurate Information	20	20
Material Discolored	18	18
Delivered as Unsterile Product	17	17
Wrong Label	16	16
Contamination	15	15
Compatibility Problem	15	15
Connection Problem	14	14
Activation, Positioning or Separation Problem	14	14
Defective Device	13	13
Failure to Align	13	13
Problem with Sterilization	13	13
Device Damaged by Another Device	12	12
Device Packaging Compromised	12	12
Material Protrusion/Extrusion	11	11
Contamination /Decontamination Problem	11	11
Output Problem	10	10
Difficult to Open or Remove Packaging Material	10	10
Unsealed Device Packaging	10	10
Physical Resistance/Sticking	10	10
Sticking	9	9
Labelling, Instructions for Use or Training Problem	9	9
Failure to Disconnect	9	9
Component Missing	9	9
Component or Accessory Incompatibility	8	8
Deformation Due to Compressive Stress	8	8
Separation Problem	8	8
Defective Component	7	7
Device Issue	7	7
Component Incompatible	7	7
Misassembled	7	7
Entrapment of Device	6	6
Incomplete or Missing Packaging	6	6
Human-Device Interface Problem	6	6
Mechanics Altered	5	5
Expiration Date Error	5	5
Device Expiration Issue	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	4598	4598
Unspecified Infection	3477	3500
Joint Dislocation	3259	3259
No Code Available	2929	2929
No Information	2095	2095
Injury	1230	1230
Bone Fracture(s)	981	983
No Clinical Signs, Symptoms or Conditions	976	976
Failure of Implant	919	919
Insufficient Information	837	837
Reaction	742	742
Inadequate Osseointegration	696	696
No Known Impact Or Consequence To Patient	595	595
Fall	493	493
Inflammation	489	489
Osteolysis	430	430
Joint Disorder	413	413
Ambulation Difficulties	411	411
Joint Laxity	400	400
Discomfort	394	394
Tissue Damage	385	385
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	382	382
Foreign Body Reaction	368	368
Metal Related Pathology	331	331
Loss of Range of Motion	325	325
Test Result	319	319
No Consequences Or Impact To Patient	291	291
Not Applicable	288	288
Limited Mobility Of The Implanted Joint	234	234
Toxicity	216	216
Host-Tissue Reaction	205	205
Hip Fracture	197	197
Swelling	194	194
Hematoma	179	179
Limb Fracture	176	176
Necrosis	165	165
Local Reaction	118	118
Hypersensitivity/Allergic reaction	110	110
Ossification	110	110
Bacterial Infection	101	101
Scar Tissue	99	99
Impaired Healing	92	92
Blood Loss	92	92
Swelling/ Edema	90	90
Implant Pain	89	89
Synovitis	88	88
Fluid Discharge	87	87
Physical Asymmetry	76	76
Wound Dehiscence	74	74
Fatigue	67	67
Unspecified Tissue Injury	67	67
Unequal Limb Length	64	64
Muscle/Tendon Damage	60	60
Osteopenia/ Osteoporosis	58	58
Adhesion(s)	57	57
Weakness	56	56
No Patient Involvement	54	54
Cyst(s)	49	49
Distress	45	45
Edema	43	43
Muscular Rigidity	43	43
Thrombosis	40	40
Fever	40	40
Pulmonary Embolism	40	40
Complaint, Ill-Defined	40	40
Hemorrhage/Bleeding	38	38
Erythema	37	37
Death	36	36
Foreign Body In Patient	36	37
Deformity/ Disfigurement	35	35
Thrombosis/Thrombus	35	35
Patient Problem/Medical Problem	33	33
Post Operative Wound Infection	33	33
Abscess	32	32
Nerve Damage	32	32
Cardiac Arrest	31	31
Subluxation	27	27
Numbness	26	26
Seroma	26	26
Disability	25	25
Arthralgia	23	23
Anxiety	23	23
Infarction, Cerebral	23	23
Device Embedded In Tissue or Plaque	22	22
Depression	20	20
Cellulitis	20	20
Rash	19	19
Myocardial Infarction	18	18
Anemia	17	17
Hearing Impairment	16	16
Nausea	16	16
Sepsis	16	16
Burning Sensation	15	15
Muscle Weakness	15	15
Unspecified Musculoskeletal problem	15	15
Non-union Bone Fracture	14	14
Sleep Dysfunction	13	13
Fibrosis	13	13
Urinary Retention	13	13
Headache	13	13

Recalls
Manufacturer		Recall Class	Date Posted
1	Aesculap Inc	II	Aug-12-2011
2	Biomet, Inc.	II	Dec-18-2023
3	Biomet, Inc.	II	May-28-2020
4	Biomet, Inc.	II	Jan-13-2016
5	Biomet, Inc.	II	Apr-23-2012
6	Biomet, Inc.	II	Mar-02-2012
7	Biomet, Inc.	II	Jul-14-2009
8	Corin Ltd	II	Dec-19-2022
9	Corin USA Limited	II	Apr-22-2016
10	DePuy Orthopaedics, Inc.	II	Dec-17-2014
11	Encore Medical, LP	II	Sep-19-2023
12	Exactech, Inc.	II	Sep-09-2022
13	Exactech, Inc.	II	Aug-12-2021
14	Exactech, Inc.	II	Jul-22-2021
15	Exactech, Inc.	II	Jan-17-2017
16	Exactech, Inc.	II	Jul-05-2016
17	Exactech, Inc.	II	Jul-21-2014
18	Exactech, Inc.	II	Feb-05-2013
19	Howmedica Osteonics Corp.	II	Mar-31-2022
20	IMPLANTCAST GMBH	II	Jul-09-2021
21	IMPLANTCAST GMBH	II	Jul-20-2018
22	Medacta Usa Inc	II	Oct-19-2018
23	MicroPort Orthopedics Inc.	II	Jan-03-2017
24	MicroPort Orthopedics Inc.	III	Dec-01-2016
25	OMNIlife science Inc.	II	Jan-26-2021
26	OMNIlife science Inc.	II	Sep-05-2019
27	Omnilife Science Inc.	II	Jul-14-2015
28	Omnilife Science Inc.	II	Aug-15-2014
29	Ortho Development Corporation	II	Jan-13-2012
30	Ortho Development Corporation	II	Mar-16-2011
31	Orthopedic Alliance LLC	II	May-24-2013
32	Smith & Nephew Inc	II	May-24-2024
33	Smith & Nephew Orthopaedics AG	II	Aug-19-2020
34	Smith & Nephew, Inc.	II	Aug-29-2017
35	Stryker Howmedica Osteonics Corp.	II	Sep-28-2012
36	Stryker Howmedica Osteonics Corp.	II	Nov-16-2011
37	Stryker Howmedica Osteonics Corp.	II	Mar-11-2010
38	Stryker Howmedica Osteonics Corp.	II	Jan-11-2010
39	Stryker Howmedica Osteonics Corp.	III	Sep-14-2009
40	Stryker Howmedica Osteonics Corp.	II	May-21-2009
41	Stryker Howmedica Osteonics Corp.	II	Jan-26-2009
42	Stryker Howmedica Osteonics Corp.	II	Jan-26-2009
43	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Feb-29-2024
44	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Aug-04-2023
45	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Jan-14-2019
46	Zimmer Biomet, Inc.	II	Nov-07-2019
47	Zimmer Biomet, Inc.	II	Apr-16-2018
48	Zimmer Biomet, Inc.	II	Mar-14-2018
49	Zimmer Biomet, Inc.	II	Dec-29-2017
50	Zimmer Biomet, Inc.	II	Mar-20-2017
51	Zimmer GmbH	II	Dec-20-2018
52	Zimmer GmbH	II	Apr-26-2018
53	Zimmer Gmbh	II	Jul-26-2016
54	Zimmer Gmbh	II	Feb-20-2015
55	Zimmer Inc.	II	Jul-27-2009
56	Zimmer, Inc.	II	Feb-27-2015
57	Zimmer, Inc.	II	Nov-06-2012