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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 1
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 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 2070 2095
2024 2589 2904
2025 367 367

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4146 4266
Device Dislodged or Dislocated 1814 1820
Fracture 855 856
Appropriate Term/Code Not Available 794 794
Insufficient Information 591 604
Osseointegration Problem 513 526
Naturally Worn 395 465
Break 297 297
Loosening of Implant Not Related to Bone-Ingrowth 243 267
Migration 220 363
Material Erosion 210 210
Device Appears to Trigger Rejection 199 199
Unstable 159 159
Loose or Intermittent Connection 159 159
Loss of Osseointegration 128 128
Noise, Audible 123 123
Corroded 120 120
Patient Device Interaction Problem 119 119
Manufacturing, Packaging or Shipping Problem 111 111
Detachment of Device or Device Component 100 100
Difficult to Insert 99 99
Tear, Rip or Hole in Device Packaging 86 86
Packaging Problem 85 85
Degraded 65 65
Failure to Osseointegrate 64 64
Inadequacy of Device Shape and/or Size 61 61
Malposition of Device 58 58
Use of Device Problem 52 52
Mechanical Problem 47 47
Device Contaminated During Manufacture or Shipping 44 44
Unintended Movement 43 43
Crack 41 41
Material Integrity Problem 39 39
Patient-Device Incompatibility 38 38
No Apparent Adverse Event 37 37
Biocompatibility 31 31
Delivered as Unsterile Product 28 28
Positioning Problem 27 27
Improper or Incorrect Procedure or Method 26 26
Migration or Expulsion of Device 26 26
Off-Label Use 24 24
Difficult to Remove 24 24
Scratched Material 23 23
Positioning Failure 22 22
Device-Device Incompatibility 22 22
Inaccurate Information 20 20
Device Damaged Prior to Use 18 18
Mechanical Jam 18 18
Wrong Label 17 17
Loss of or Failure to Bond 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1892 1960
Unspecified Infection 1832 1876
Joint Dislocation 1814 1833
No Clinical Signs, Symptoms or Conditions 1206 1250
Insufficient Information 1027 1146
Failure of Implant 913 968
Inadequate Osseointegration 638 651
No Code Available 611 611
Bone Fracture(s) 562 583
Joint Laxity 499 499
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 418 418
Metal Related Pathology 360 360
Fall 327 327
Osteolysis 241 289
Ambulation Difficulties 226 226
Limb Fracture 220 220
Foreign Body Reaction 193 193
Loss of Range of Motion 152 152
Implant Pain 148 148
No Known Impact Or Consequence To Patient 136 136
No Information 124 124
Swelling/ Edema 111 111
Discomfort 103 103
Inflammation 103 103
Injury 97 97
Physical Asymmetry 95 95
Unequal Limb Length 89 89
Hip Fracture 85 85
Hematoma 83 83
Ossification 77 77
Unspecified Tissue Injury 76 76
Bacterial Infection 76 76
Joint Disorder 76 76
Scar Tissue 70 70
Hypersensitivity/Allergic reaction 69 69
Muscle/Tendon Damage 67 67
Fluid Discharge 66 66
Necrosis 66 66
No Consequences Or Impact To Patient 57 57
Synovitis 55 55
Adhesion(s) 45 45
Thrombosis/Thrombus 41 41
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
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