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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 6
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 2064 2156
2024 2586 2946
2025 3272 4824

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5052 5910
Device Dislodged or Dislocated 1775 2112
Fracture 890 917
Osseointegration Problem 580 598
Insufficient Information 560 591
Appropriate Term/Code Not Available 540 550
Naturally Worn 390 516
Device Appears to Trigger Rejection 285 287
Loosening of Implant Not Related to Bone-Ingrowth 255 428
Material Erosion 246 334
Migration 244 390
Break 226 230
Tear, Rip or Hole in Device Packaging 174 175
Manufacturing, Packaging or Shipping Problem 153 153
Loss of Osseointegration 142 221
Unstable 136 137
Noise, Audible 125 137
Patient Device Interaction Problem 119 124
Packaging Problem 117 117
Detachment of Device or Device Component 116 121
Difficult to Insert 105 106
Loose or Intermittent Connection 90 90
Corroded 89 101
Delivered as Unsterile Product 72 72
Failure to Osseointegrate 68 68
Degraded 67 70
Malposition of Device 57 92
Patient-Device Incompatibility 52 52
Inadequacy of Device Shape and/or Size 48 48
Use of Device Problem 48 48
Device Contaminated During Manufacture or Shipping 43 43
Mechanical Problem 42 43
Material Integrity Problem 41 45
Crack 38 38
No Apparent Adverse Event 36 37
Unintended Movement 32 33
Biocompatibility 29 30
Off-Label Use 27 27
Positioning Failure 26 26
Improper or Incorrect Procedure or Method 26 26
Positioning Problem 26 26
Device-Device Incompatibility 24 24
Difficult to Remove 22 24
Migration or Expulsion of Device 21 23
Scratched Material 18 18
Inaccurate Information 18 18
Wrong Label 18 18
Device Damaged Prior to Use 17 17
Mechanical Jam 17 19
Separation Failure 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2058 2174
Joint Dislocation 1928 2299
Pain 1913 2136
No Clinical Signs, Symptoms or Conditions 1571 1993
Insufficient Information 1278 1530
Failure of Implant 930 1033
Inadequate Osseointegration 679 700
Bone Fracture(s) 615 672
Joint Laxity 610 637
Metal Related Pathology 469 685
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 394 401
Fall 335 344
Limb Fracture 289 291
Osteolysis 276 338
Ambulation Difficulties 258 276
Foreign Body Reaction 189 211
Implant Pain 174 205
Loss of Range of Motion 159 189
Swelling/ Edema 135 148
Unequal Limb Length 125 128
Physical Asymmetry 115 120
Inflammation 101 104
Discomfort 96 101
Hematoma 93 97
Unspecified Tissue Injury 86 93
Ossification 83 97
Scar Tissue 81 91
Fluid Discharge 76 77
Muscle/Tendon Damage 75 86
Bacterial Infection 75 78
Hypersensitivity/Allergic reaction 73 84
Thrombosis/Thrombus 64 66
Hip Fracture 64 68
Necrosis 61 67
Synovitis 54 61
Post Operative Wound Infection 48 96
Wound Dehiscence 46 48
Hemorrhage/Bleeding 45 51
Subluxation 44 53
Nerve Damage 38 42
Foreign Body In Patient 38 42
Erythema 35 36
Osteopenia/ Osteoporosis 31 35
Adhesion(s) 30 36
Sepsis 29 29
Fatigue 29 32
Impaired Healing 28 48
Distress 27 42
Fever 26 26
Non-union Bone Fracture 24 24

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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