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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 3273 4824
2026 199 1238

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5156 7053
Device Dislodged or Dislocated 1819 2156
Fracture 903 942
Osseointegration Problem 587 652
Insufficient Information 564 594
Appropriate Term/Code Not Available 540 550
Naturally Worn 391 517
Device Appears to Trigger Rejection 288 290
Loosening of Implant Not Related to Bone-Ingrowth 260 1425
Material Erosion 254 1369
Migration 246 392
Break 226 230
Tear, Rip or Hole in Device Packaging 180 181
Manufacturing, Packaging or Shipping Problem 154 154
Loss of Osseointegration 142 221
Unstable 139 140
Noise, Audible 127 139
Patient Device Interaction Problem 123 128
Detachment of Device or Device Component 118 123
Packaging Problem 117 117
Difficult to Insert 105 106
Loose or Intermittent Connection 90 90
Corroded 89 101
Delivered as Unsterile Product 76 76
Failure to Osseointegrate 68 68
Degraded 67 70
Malposition of Device 61 1106
Patient-Device Incompatibility 52 52
Use of Device Problem 50 50
Inadequacy of Device Shape and/or Size 48 48
Device Contaminated During Manufacture or Shipping 45 45
Mechanical Problem 43 44
Material Integrity Problem 41 45
Crack 38 38
No Apparent Adverse Event 36 37
Unintended Movement 32 33
Biocompatibility 29 30
Improper or Incorrect Procedure or Method 28 28
Positioning Failure 27 27
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
Scratched Material 18 18
Inaccurate Information 18 18
Wrong Label 18 18
Mechanical Jam 17 19
Device Damaged Prior to Use 17 17
Separation Failure 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2103 3258
Joint Dislocation 1974 3372
Pain 1936 2159
No Clinical Signs, Symptoms or Conditions 1591 2013
Insufficient Information 1296 2551
Failure of Implant 931 1034
Inadequate Osseointegration 684 705
Joint Laxity 626 688
Bone Fracture(s) 625 682
Metal Related Pathology 473 724
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 397 404
Fall 336 345
Limb Fracture 294 296
Osteolysis 287 349
Ambulation Difficulties 260 278
Foreign Body Reaction 189 211
Implant Pain 178 209
Loss of Range of Motion 160 190
Swelling/ Edema 135 148
Unequal Limb Length 127 130
Physical Asymmetry 118 123
Inflammation 102 105
Discomfort 98 103
Hematoma 93 97
Ossification 87 101
Unspecified Tissue Injury 86 93
Scar Tissue 81 91
Fluid Discharge 77 78
Muscle/Tendon Damage 77 88
Bacterial Infection 76 79
Hypersensitivity/Allergic reaction 73 84
Thrombosis/Thrombus 66 68
Hip Fracture 64 68
Necrosis 61 67
Synovitis 54 61
Post Operative Wound Infection 53 101
Wound Dehiscence 46 48
Hemorrhage/Bleeding 46 52
Subluxation 44 53
Nerve Damage 38 42
Foreign Body In Patient 38 42
Erythema 35 36
Osteopenia/ Osteoporosis 31 35
Adhesion(s) 30 36
Fatigue 29 32
Sepsis 29 29
Impaired Healing 28 48
Distress 27 42
Fever 26 26
Cyst(s) 25 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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