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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product CodeLPH
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
ADLER ORTHO S.P.A
  SUBSTANTIALLY EQUIVALENT 1
BIOCORE9, LLC
  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 4
MERIL HEALTHCARE PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  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
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

MDR Year MDR Reports MDR Events
2021 5978 6045
2022 5224 5326
2023 5345 5460
2024 5628 5655
2025 6276 8580

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13215 15135
Device Dislodged or Dislocated 5556 6448
Naturally Worn 1664 1721
Fracture 1457 2313
Osseointegration Problem 1184 2142
Material Erosion 889 2259
Insufficient Information 726 1243
Degraded 680 692
Difficult to Insert 561 564
Migration 550 553
Detachment of Device or Device Component 530 534
Loosening of Implant Not Related to Bone-Ingrowth 492 1591
Appropriate Term/Code Not Available 414 416
Corroded 389 407
Noise, Audible 317 334
Unstable 315 318
Use of Device Problem 304 305
Loss of Osseointegration 299 299
Manufacturing, Packaging or Shipping Problem 194 194
Loss of or Failure to Bond 193 193
Malposition of Device 189 1215
Tear, Rip or Hole in Device Packaging 189 189
Packaging Problem 180 180
Device-Device Incompatibility 138 141
Patient Device Interaction Problem 100 103
Break 98 104
Positioning Failure 91 91
Off-Label Use 81 82
Device Contaminated During Manufacture or Shipping 77 77
Difficult to Remove 74 74
Device Appears to Trigger Rejection 71 71
Material Deformation 69 70
No Apparent Adverse Event 67 68
Delivered as Unsterile Product 63 63
Separation Failure 61 62
Unintended Movement 59 60
Positioning Problem 51 51
Failure to Osseointegrate 41 42
Mechanical Problem 36 36
Improper or Incorrect Procedure or Method 34 812
Biocompatibility 32 35
Inadequacy of Device Shape and/or Size 31 31
Loose or Intermittent Connection 30 31
Difficult to Advance 28 28
Migration or Expulsion of Device 25 25
Material Integrity Problem 17 17
Material Twisted/Bent 16 16
Defective Device 14 14
Mechanical Jam 14 14
Device Difficult to Setup or Prepare 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6156 7288
Joint Dislocation 4744 6762
Unspecified Infection 4662 6172
Insufficient Information 3926 5447
Joint Laxity 2357 3549
No Clinical Signs, Symptoms or Conditions 2139 2166
Metal Related Pathology 2051 2725
Foreign Body Reaction 1687 1756
Inadequate Osseointegration 1490 1558
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1388 1428
Ambulation Difficulties 1158 1205
Failure of Implant 1045 1161
Bone Fracture(s) 939 1618
Osteolysis 907 1900
Fall 834 846
Swelling/ Edema 745 784
Limb Fracture 700 701
Unspecified Tissue Injury 673 725
Loss of Range of Motion 646 697
Discomfort 525 553
Hypersensitivity/Allergic reaction 505 547
Inflammation 437 459
Necrosis 360 928
Scar Tissue 359 389
Muscle/Tendon Damage 341 364
Distress 331 374
Ossification 289 845
Physical Asymmetry 275 288
Synovitis 272 836
Hematoma 270 398
Adhesion(s) 259 281
Fatigue 230 247
Fluid Discharge 208 209
Nerve Damage 170 178
Thrombosis/Thrombus 167 171
Hemorrhage/Bleeding 154 157
Unequal Limb Length 149 690
Muscular Rigidity 142 157
Deformity/ Disfigurement 121 1463
Impaired Healing 117 273
Numbness 114 125
Cyst(s) 113 128
Wound Dehiscence 106 113
Osteopenia/ Osteoporosis 99 103
Erythema 94 95
Implant Pain 91 91
Bacterial Infection 90 95
Post Operative Wound Infection 89 103
Anxiety 87 95
Pulmonary Embolism 84 87

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 Jul-21-2025
5 Encore Medical, LP II Oct-12-2023
6 Encore Medical, LP II Oct-21-2022
7 Exactech, Inc. II Feb-12-2025
8 Exactech, Inc. II Jan-18-2024
9 Exactech, Inc. II Sep-09-2022
10 Exactech, Inc. II Jul-22-2021
11 Howmedica Osteonics Corp. II Apr-25-2024
12 Howmedica Osteonics Corp. II Feb-16-2022
13 Limacorporate S.p.A II Oct-21-2021
14 Novosource, LLC II Nov-18-2024
15 OmniLife Science II Nov-16-2021
16 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-26-2023
17 Zimmer, Inc. II Nov-03-2025
18 Zimmer, Inc. II Mar-29-2023
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