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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 6
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 2
ORCHARD MEDICAL DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORCHARD MEDICAL DEVELOPMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SERF
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
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 2
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 1959 1959
2021 2200 2200
2022 1987 1987
2023 2073 2098
2024 2594 2909
2025 1294 1699

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4562 4758
Device Dislodged or Dislocated 1941 1951
Fracture 898 899
Appropriate Term/Code Not Available 800 800
Insufficient Information 661 674
Osseointegration Problem 538 551
Naturally Worn 404 474
Break 303 303
Loosening of Implant Not Related to Bone-Ingrowth 263 290
Material Erosion 254 254
Migration 236 379
Device Appears to Trigger Rejection 219 219
Unstable 165 165
Manufacturing, Packaging or Shipping Problem 161 161
Loose or Intermittent Connection 159 159
Loss of Osseointegration 144 146
Noise, Audible 135 135
Corroded 123 123
Patient Device Interaction Problem 122 122
Difficult to Insert 109 109
Packaging Problem 107 107
Detachment of Device or Device Component 105 105
Tear, Rip or Hole in Device Packaging 102 102
Degraded 67 67
Failure to Osseointegrate 64 64
Malposition of Device 62 62
Inadequacy of Device Shape and/or Size 62 62
Use of Device Problem 54 54
Patient-Device Incompatibility 49 49
Mechanical Problem 47 47
Device Contaminated During Manufacture or Shipping 45 45
Unintended Movement 43 43
Crack 42 42
Delivered as Unsterile Product 42 42
No Apparent Adverse Event 40 40
Material Integrity Problem 39 39
Biocompatibility 31 31
Positioning Problem 29 29
Improper or Incorrect Procedure or Method 26 26
Migration or Expulsion of Device 26 26
Off-Label Use 26 26
Device-Device Incompatibility 25 25
Difficult to Remove 24 24
Scratched Material 23 23
Positioning Failure 23 23
Inaccurate Information 20 20
Separation Failure 20 20
Mechanical Jam 19 19
Loss of or Failure to Bond 18 18
Device Damaged Prior to Use 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2009 2077
Unspecified Infection 1993 2045
Joint Dislocation 1950 1973
No Clinical Signs, Symptoms or Conditions 1360 1724
Insufficient Information 1182 1343
Failure of Implant 994 1051
Inadequate Osseointegration 666 681
Bone Fracture(s) 620 661
No Code Available 611 611
Joint Laxity 527 527
Metal Related Pathology 422 422
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 420 420
Fall 336 336
Osteolysis 272 320
Ambulation Difficulties 243 243
Limb Fracture 243 243
Foreign Body Reaction 197 197
Loss of Range of Motion 159 166
Implant Pain 156 156
No Known Impact Or Consequence To Patient 136 136
No Information 124 124
Swelling/ Edema 123 123
Inflammation 109 109
Discomfort 108 108
Physical Asymmetry 104 104
Unequal Limb Length 101 101
Injury 97 97
Hematoma 88 88
Hip Fracture 87 87
Unspecified Tissue Injury 83 83
Ossification 81 88
Scar Tissue 77 77
Bacterial Infection 76 76
Joint Disorder 76 76
Hypersensitivity/Allergic reaction 74 74
Necrosis 73 73
Muscle/Tendon Damage 70 70
Fluid Discharge 69 69
Synovitis 61 61
No Consequences Or Impact To Patient 57 57
Thrombosis/Thrombus 50 50
Adhesion(s) 45 45
Hemorrhage/Bleeding 45 45
Local Reaction 41 41
Fatigue 39 39
Osteopenia/ Osteoporosis 39 39
Wound Dehiscence 37 37
Erythema 36 36
Foreign Body In Patient 36 36
Tissue Damage 35 35

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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