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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 1
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET UK LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 5
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 4
KYOCERA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 7
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORCHARD MEDICAL DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORCHARD MEDICAL DEVELOPMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SERF
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 4
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
WALDEMAR LINK GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
XERXES ARTHOPEDIX LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1958 1958
2021 2200 2200
2022 1987 1987
2023 2068 2093
2024 2591 2906
2025 638 638

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4282 4402
Device Dislodged or Dislocated 1837 1843
Fracture 864 865
Appropriate Term/Code Not Available 797 797
Insufficient Information 612 625
Osseointegration Problem 522 535
Naturally Worn 396 466
Break 298 298
Loosening of Implant Not Related to Bone-Ingrowth 250 274
Migration 222 365
Material Erosion 220 220
Device Appears to Trigger Rejection 205 205
Unstable 159 159
Loose or Intermittent Connection 159 159
Loss of Osseointegration 132 132
Noise, Audible 123 123
Corroded 121 121
Patient Device Interaction Problem 119 119
Manufacturing, Packaging or Shipping Problem 119 119
Detachment of Device or Device Component 102 102
Difficult to Insert 101 101
Packaging Problem 100 100
Tear, Rip or Hole in Device Packaging 91 91
Degraded 66 66
Failure to Osseointegrate 64 64
Inadequacy of Device Shape and/or Size 62 62
Malposition of Device 60 60
Use of Device Problem 52 52
Mechanical Problem 47 47
Device Contaminated During Manufacture or Shipping 44 44
Unintended Movement 43 43
Crack 42 42
Patient-Device Incompatibility 40 40
Material Integrity Problem 39 39
No Apparent Adverse Event 38 38
Delivered as Unsterile Product 36 36
Biocompatibility 31 31
Positioning Problem 27 27
Improper or Incorrect Procedure or Method 26 26
Migration or Expulsion of Device 26 26
Off-Label Use 25 25
Difficult to Remove 24 24
Device-Device Incompatibility 23 23
Scratched Material 23 23
Positioning Failure 23 23
Inaccurate Information 20 20
Mechanical Jam 18 18
Device Damaged Prior to Use 18 18
Loss of or Failure to Bond 17 17
Wrong Label 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1920 1988
Unspecified Infection 1867 1911
Joint Dislocation 1840 1859
No Clinical Signs, Symptoms or Conditions 1258 1302
Insufficient Information 1114 1233
Failure of Implant 931 986
Inadequate Osseointegration 647 660
No Code Available 611 611
Bone Fracture(s) 570 591
Joint Laxity 504 504
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 419 419
Metal Related Pathology 369 369
Fall 329 329
Osteolysis 243 291
Ambulation Difficulties 228 228
Limb Fracture 221 221
Foreign Body Reaction 194 194
Loss of Range of Motion 154 154
Implant Pain 149 149
No Known Impact Or Consequence To Patient 136 136
No Information 124 124
Swelling/ Edema 111 111
Discomfort 105 105
Inflammation 104 104
Injury 97 97
Physical Asymmetry 96 96
Unequal Limb Length 93 93
Hip Fracture 87 87
Hematoma 85 85
Unspecified Tissue Injury 79 79
Ossification 78 78
Bacterial Infection 76 76
Joint Disorder 76 76
Scar Tissue 72 72
Hypersensitivity/Allergic reaction 69 69
Muscle/Tendon Damage 68 68
Necrosis 68 68
Fluid Discharge 66 66
No Consequences Or Impact To Patient 57 57
Synovitis 55 55
Adhesion(s) 45 45
Thrombosis/Thrombus 45 45
Hemorrhage/Bleeding 39 39
Fatigue 38 38
Wound Dehiscence 37 37
Osteopenia/ Osteoporosis 37 37
Local Reaction 37 37
Tissue Damage 35 35
Foreign Body In Patient 34 34
Limited Mobility Of The Implanted Joint 33 33

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-18-2023
2 Biomet, Inc. II May-28-2020
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 Smith & Nephew Orthopaedics AG II Aug-19-2020
13 Waldemar Link GmbH & Co. KG (Mfg Site) II Dec-26-2024
14 Waldemar Link GmbH & Co. KG (Mfg Site) II Feb-29-2024
15 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-04-2023
16 Zimmer GmbH II Sep-12-2024
17 Zimmer, Inc. II Apr-21-2025
18 Zimmer, Inc. II Mar-24-2025
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