TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
ADLER ORTHO S.P.A
	SUBSTANTIALLY EQUIVALENT	1
BIOCORE9, LLC
	SUBSTANTIALLY EQUIVALENT	1
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORENTEC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4
CORIN U.S.A. LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DEPUY INTERNATIONAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
DEPUY IRELAND UC
	SUBSTANTIALLY EQUIVALENT	5
ENCORE MEDICAL L.P.
	SUBSTANTIALLY EQUIVALENT	2
ENCORE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
GLOBUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
HOWMEDICA OSTEONICS CORP (DBA STRYKER ORTHOPAEDICS)
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP. A.K.A. STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	4
KYOCERA MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIMA CORPORATE S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
MEDACTA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	5
MERIL HEALTHCARE PVT. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
MICROPORT ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEXTSTEP ARTHOPEDIX, LLC
	SUBSTANTIALLY EQUIVALENT	1
ONKOS SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
ONKOS SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO DEVELOPMENT CORP.
	SUBSTANTIALLY EQUIVALENT	1
RESTOR3D, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHALBY ADVANCED TECHNOLOGIES, INC. DBA CONSENSUS ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	5
THEKEN COMPANIES
	SUBSTANTIALLY EQUIVALENT	1
UNITED ORTHOPEDIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WALDEMAR LINK GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	3
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	5978	6045
2022	5223	5325
2023	5344	5459
2024	5626	5653
2025	6246	11960
2026	2126	2360

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	14125	19724
Device Dislodged or Dislocated	5988	8373
Naturally Worn	1780	1837
Fracture	1533	5509
Osseointegration Problem	1265	5227
Material Erosion	1002	6149
Insufficient Information	735	1470
Degraded	710	722
Difficult to Insert	595	598
Migration	585	588
Detachment of Device or Device Component	575	579
Loosening of Implant Not Related to Bone-Ingrowth	552	3954
Appropriate Term/Code Not Available	414	416
Corroded	397	415
Unstable	343	346
Noise, Audible	336	353
Tear, Rip or Hole in Device Packaging	326	326
Use of Device Problem	322	323
Loss of Osseointegration	313	313
Loss of or Failure to Bond	213	213
Malposition of Device	205	3655
Manufacturing, Packaging or Shipping Problem	195	195
Packaging Problem	185	185
Device-Device Incompatibility	141	144
Delivered as Unsterile Product	130	130
Patient Device Interaction Problem	114	117
Break	108	114
Positioning Failure	100	100
Device Contaminated During Manufacture or Shipping	91	91
Off-Label Use	81	82
No Apparent Adverse Event	75	76
Device Appears to Trigger Rejection	75	75
Difficult to Remove	75	75
Material Deformation	72	73
Separation Failure	65	66
Unintended Movement	60	61
Positioning Problem	53	53
Failure to Osseointegrate	42	43
Mechanical Problem	39	39
Improper or Incorrect Procedure or Method	38	3725
Inadequacy of Device Shape and/or Size	35	35
Biocompatibility	33	36
Loose or Intermittent Connection	30	31
Difficult to Advance	28	28
Migration or Expulsion of Device	25	25
Material Integrity Problem	18	18
Material Twisted/Bent	18	18
Product Quality Problem	16	16
Mechanical Jam	15	15
Defective Device	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	6440	10588
Joint Dislocation	5151	10795
Unspecified Infection	4985	10156
Insufficient Information	4199	9381
Joint Laxity	2585	5910
No Clinical Signs, Symptoms or Conditions	2390	2417
Metal Related Pathology	2218	4649
Foreign Body Reaction	1754	1823
Inadequate Osseointegration	1589	2201
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1389	1429
Ambulation Difficulties	1222	1269
Failure of Implant	1055	1171
Bone Fracture(s)	984	2583
Osteolysis	954	4951
Fall	874	886
Swelling/ Edema	762	801
Limb Fracture	741	742
Unspecified Tissue Injury	685	737
Loss of Range of Motion	666	717
Hypersensitivity/Allergic reaction	538	580
Discomfort	532	560
Inflammation	450	472
Scar Tissue	378	408
Necrosis	373	2482
Muscle/Tendon Damage	355	378
Distress	329	372
Ossification	302	2399
Synovitis	289	2394
Physical Asymmetry	288	301
Hematoma	286	572
Adhesion(s)	261	283
Fatigue	237	255
Fluid Discharge	225	226
Nerve Damage	177	185
Hemorrhage/Bleeding	175	178
Thrombosis/Thrombus	170	174
Unequal Limb Length	168	2466
Muscular Rigidity	144	159
Wound Dehiscence	128	135
Cyst(s)	124	139
Impaired Healing	123	437
Deformity/ Disfigurement	122	4761
Numbness	116	127
Bacterial Infection	106	111
Osteopenia/ Osteoporosis	103	107
Erythema	98	99
Implant Pain	97	97
Post Operative Wound Infection	95	109
Pulmonary Embolism	90	93
Anxiety	89	97

Recalls
Manufacturer		Recall Class	Date Posted
1	BioPro, Inc.	II	Oct-14-2025
2	Biomet, Inc.	II	Mar-23-2023
3	Conformis Inc.	II	Apr-15-2025
4	Encore Medical, LP	II	Feb-02-2026
5	Encore Medical, LP	II	Jul-21-2025
6	Encore Medical, LP	II	Oct-12-2023
7	Encore Medical, LP	II	Oct-21-2022
8	Exactech, Inc.	II	Feb-12-2025
9	Exactech, Inc.	II	Jan-18-2024
10	Exactech, Inc.	II	Sep-09-2022
11	Exactech, Inc.	II	Jul-22-2021
12	Howmedica Osteonics Corp.	II	Apr-25-2024
13	Howmedica Osteonics Corp.	II	Feb-16-2022
14	Limacorporate S.p.A	II	Oct-21-2021
15	Novosource, LLC	II	Nov-18-2024
16	OmniLife Science	II	Nov-16-2021
17	Waldemar Link GmbH & Co. KG (Mfg Site)	II	Sep-26-2023
18	Zimmer, Inc.	II	Nov-03-2025
19	Zimmer, Inc.	II	Mar-29-2023