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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/ceramic/polymer, cemented or non-porous, uncemented
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product CodeLZO
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN U.S.A. LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CORIN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 6
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 3
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 8
KYOCERA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIMA CORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 7
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORCHARD MEDICAL DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORCHARD MEDICAL DEVELOPMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SERF
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 4
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
XERXES ARTHOPEDIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2199 2241
2022 1985 2055
2023 2062 2154
2024 2586 2946
2025 3287 4838
2026 634 1673

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5362 7259
Device Dislodged or Dislocated 1877 2214
Fracture 946 985
Osseointegration Problem 606 671
Insufficient Information 604 634
Appropriate Term/Code Not Available 552 562
Naturally Worn 402 528
Device Appears to Trigger Rejection 301 303
Loosening of Implant Not Related to Bone-Ingrowth 275 1440
Material Erosion 262 1377
Migration 256 402
Break 232 236
Tear, Rip or Hole in Device Packaging 194 195
Manufacturing, Packaging or Shipping Problem 154 154
Unstable 148 149
Loss of Osseointegration 146 225
Noise, Audible 130 142
Patient Device Interaction Problem 126 131
Detachment of Device or Device Component 123 128
Packaging Problem 117 117
Difficult to Insert 107 108
Loose or Intermittent Connection 90 90
Corroded 89 101
Delivered as Unsterile Product 83 83
Degraded 70 73
Failure to Osseointegrate 69 69
Malposition of Device 63 1108
Patient-Device Incompatibility 53 53
Use of Device Problem 52 52
Inadequacy of Device Shape and/or Size 50 50
Device Contaminated During Manufacture or Shipping 47 47
Mechanical Problem 46 47
Material Integrity Problem 42 46
Crack 39 39
No Apparent Adverse Event 37 38
Unintended Movement 36 37
Improper or Incorrect Procedure or Method 32 32
Biocompatibility 29 30
Positioning Failure 28 28
Positioning Problem 27 27
Off-Label Use 27 27
Device-Device Incompatibility 25 25
Difficult to Remove 22 24
Migration or Expulsion of Device 21 23
Wrong Label 19 19
Loss of or Failure to Bond 19 20
Inaccurate Information 18 18
Scratched Material 18 18
Separation Failure 18 18
Mechanical Jam 18 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2176 3331
Joint Dislocation 2035 3433
Pain 1974 2198
No Clinical Signs, Symptoms or Conditions 1650 2072
Insufficient Information 1362 2617
Failure of Implant 933 1036
Inadequate Osseointegration 700 721
Joint Laxity 656 718
Bone Fracture(s) 645 702
Metal Related Pathology 487 738
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 401 408
Fall 344 353
Limb Fracture 311 313
Osteolysis 292 355
Ambulation Difficulties 277 295
Foreign Body Reaction 195 217
Implant Pain 182 213
Loss of Range of Motion 160 190
Unequal Limb Length 135 138
Swelling/ Edema 135 148
Physical Asymmetry 120 125
Inflammation 104 107
Discomfort 101 106
Hematoma 99 103
Ossification 90 104
Unspecified Tissue Injury 86 93
Fluid Discharge 82 83
Scar Tissue 81 91
Muscle/Tendon Damage 78 89
Hypersensitivity/Allergic reaction 76 87
Bacterial Infection 76 79
Thrombosis/Thrombus 69 71
Hip Fracture 64 68
Necrosis 62 68
Synovitis 55 63
Post Operative Wound Infection 53 101
Wound Dehiscence 47 49
Hemorrhage/Bleeding 46 52
Subluxation 43 52
Foreign Body In Patient 39 43
Nerve Damage 38 42
Erythema 36 37
Osteopenia/ Osteoporosis 33 37
Impaired Healing 30 50
Adhesion(s) 30 36
Fatigue 29 32
Sepsis 29 29
Non-union Bone Fracture 29 29
Distress 27 42
Fever 26 26

Recalls
Manufacturer Recall Class Date Posted
1 BioPro, Inc. II Oct-14-2025
2 Biomet, Inc. II Dec-18-2023
3 Corin Ltd II Dec-19-2022
4 Encore Medical, LP II Sep-19-2023
5 Exactech, Inc. II Sep-09-2022
6 Exactech, Inc. II Aug-12-2021
7 Exactech, Inc. II Jul-22-2021
8 Howmedica Osteonics Corp. II Mar-31-2022
9 IMPLANTCAST GMBH II Jul-09-2021
10 OMNIlife science Inc. II Jan-26-2021
11 Smith & Nephew Inc II May-24-2024
12 Waldemar Link GmbH & Co. KG (Mfg Site) II Dec-26-2024
13 Waldemar Link GmbH & Co. KG (Mfg Site) II Feb-29-2024
14 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-04-2023
15 Zimmer GmbH II Sep-12-2024
16 Zimmer, Inc. II Apr-21-2025
17 Zimmer, Inc. II Mar-24-2025
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