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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 2062 2154
2024 2586 2946
2025 3286 4837
2026 371 1410

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5229 7126
Device Dislodged or Dislocated 1847 2184
Fracture 937 976
Osseointegration Problem 594 659
Insufficient Information 577 607
Appropriate Term/Code Not Available 552 562
Naturally Worn 396 522
Device Appears to Trigger Rejection 294 296
Loosening of Implant Not Related to Bone-Ingrowth 264 1429
Material Erosion 256 1371
Migration 249 395
Break 230 234
Tear, Rip or Hole in Device Packaging 186 187
Manufacturing, Packaging or Shipping Problem 154 154
Unstable 146 147
Loss of Osseointegration 142 221
Noise, Audible 130 142
Patient Device Interaction Problem 125 130
Detachment of Device or Device Component 120 125
Packaging Problem 117 117
Difficult to Insert 106 107
Loose or Intermittent Connection 90 90
Corroded 89 101
Delivered as Unsterile Product 76 76
Degraded 69 72
Failure to Osseointegrate 68 68
Malposition of Device 62 1107
Patient-Device Incompatibility 53 53
Use of Device Problem 52 52
Inadequacy of Device Shape and/or Size 49 49
Device Contaminated During Manufacture or Shipping 46 46
Mechanical Problem 43 44
Material Integrity Problem 42 46
Crack 39 39
No Apparent Adverse Event 37 38
Unintended Movement 34 35
Improper or Incorrect Procedure or Method 29 29
Biocompatibility 29 30
Positioning Failure 28 28
Off-Label Use 27 27
Positioning Problem 26 26
Device-Device Incompatibility 25 25
Difficult to Remove 22 24
Migration or Expulsion of Device 21 23
Wrong Label 19 19
Mechanical Jam 18 20
Inaccurate Information 18 18
Scratched Material 18 18
Device Damaged Prior to Use 17 17
Loss of or Failure to Bond 17 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2134 3289
Joint Dislocation 2000 3398
Pain 1948 2172
No Clinical Signs, Symptoms or Conditions 1626 2048
Insufficient Information 1319 2574
Failure of Implant 932 1035
Inadequate Osseointegration 690 711
Joint Laxity 642 704
Bone Fracture(s) 634 691
Metal Related Pathology 478 729
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 401 408
Fall 341 350
Limb Fracture 301 303
Osteolysis 289 352
Ambulation Difficulties 269 287
Foreign Body Reaction 192 214
Implant Pain 179 210
Loss of Range of Motion 159 189
Swelling/ Edema 135 148
Unequal Limb Length 129 132
Physical Asymmetry 119 124
Inflammation 103 106
Discomfort 100 105
Hematoma 94 98
Ossification 87 101
Unspecified Tissue Injury 86 93
Scar Tissue 81 91
Fluid Discharge 80 81
Muscle/Tendon Damage 77 88
Bacterial Infection 76 79
Hypersensitivity/Allergic reaction 74 85
Thrombosis/Thrombus 66 68
Hip Fracture 64 68
Necrosis 61 67
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 35 36
Osteopenia/ Osteoporosis 32 36
Adhesion(s) 30 36
Fatigue 29 32
Sepsis 29 29
Impaired Healing 28 48
Distress 27 42
Fever 26 26
Cyst(s) 26 27

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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