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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 8
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 2

MDR Year MDR Reports MDR Events
2021 2199 2241
2022 1985 2055
2023 2064 2156
2024 2586 2946
2025 3291 5933
2026 1102 6999

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5523 13368
Device Dislodged or Dislocated 1949 4096
Fracture 997 4126
Insufficient Information 654 685
Osseointegration Problem 621 4207
Appropriate Term/Code Not Available 553 563
Naturally Worn 409 535
Device Appears to Trigger Rejection 319 321
Loosening of Implant Not Related to Bone-Ingrowth 291 4994
Material Erosion 276 6414
Migration 262 408
Break 238 242
Tear, Rip or Hole in Device Packaging 207 208
Unstable 165 167
Loss of Osseointegration 160 239
Manufacturing, Packaging or Shipping Problem 154 154
Detachment of Device or Device Component 144 149
Noise, Audible 134 146
Patient Device Interaction Problem 126 131
Packaging Problem 118 118
Difficult to Insert 111 112
Delivered as Unsterile Product 90 90
Loose or Intermittent Connection 90 90
Corroded 89 101
Degraded 75 78
Malposition of Device 71 4136
Failure to Osseointegrate 69 69
Patient-Device Incompatibility 53 53
Use of Device Problem 52 52
Inadequacy of Device Shape and/or Size 51 51
Device Contaminated During Manufacture or Shipping 49 49
Mechanical Problem 49 50
Material Integrity Problem 42 46
Crack 39 39
No Apparent Adverse Event 37 38
Unintended Movement 36 37
Improper or Incorrect Procedure or Method 35 2138
Biocompatibility 32 33
Positioning Failure 30 30
Positioning Problem 27 27
Off-Label Use 27 27
Device-Device Incompatibility 26 26
Difficult to Remove 23 25
Migration or Expulsion of Device 22 24
Loss of or Failure to Bond 22 23
Wrong Label 19 19
Mechanical Jam 19 21
Separation Failure 18 18
Inaccurate Information 18 18
Scratched Material 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2258 8686
Joint Dislocation 2108 8791
Pain 2050 5403
No Clinical Signs, Symptoms or Conditions 1710 2132
Insufficient Information 1456 8490
Failure of Implant 934 1037
Inadequate Osseointegration 715 736
Joint Laxity 700 2225
Bone Fracture(s) 677 1871
Metal Related Pathology 507 2221
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 403 410
Fall 354 363
Limb Fracture 322 324
Osteolysis 312 3479
Ambulation Difficulties 292 310
Foreign Body Reaction 200 222
Implant Pain 191 222
Loss of Range of Motion 164 194
Unequal Limb Length 145 1440
Swelling/ Edema 142 156
Physical Asymmetry 124 129
Inflammation 104 107
Hematoma 104 132
Discomfort 104 109
Ossification 96 371
Unspecified Tissue Injury 89 96
Muscle/Tendon Damage 83 94
Fluid Discharge 83 84
Scar Tissue 81 91
Hypersensitivity/Allergic reaction 80 91
Bacterial Infection 77 80
Thrombosis/Thrombus 70 72
Necrosis 66 72
Hip Fracture 64 68
Synovitis 63 71
Post Operative Wound Infection 53 101
Wound Dehiscence 51 53
Hemorrhage/Bleeding 47 53
Subluxation 44 53
Nerve Damage 43 47
Foreign Body In Patient 41 45
Erythema 36 37
Osteopenia/ Osteoporosis 33 37
Adhesion(s) 32 38
Impaired Healing 32 76
Non-union Bone Fracture 30 30
Cyst(s) 30 31
Distress 29 44
Sepsis 29 29
Fatigue 29 32

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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