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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
  1.  K203175  POLARSTEM Cemented Femoral Stem
  2.  K211548  POLARSTEM Calcar Reamer Guide
  3.  K240381  CATALYSTEM Femoral Stems
  4.  K250571  CATALYSTEM Femoral Stems
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 5
XERXES ARTHOPEDIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 2199 2241
2022 1985 2055
2023 2063 2155
2024 2586 2946
2025 3292 5934
2026 1594 7491

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5594 13439
Device Dislodged or Dislocated 1886 4031
Fracture 980 4109
Insufficient Device Problem Information 664 695
Osseointegration Problem 640 4226
Naturally Worn 411 537
Device Appears to Trigger Rejection 340 342
Material Erosion 287 6425
Migration 267 413
Loosening of Implant Not Related to Bone-Ingrowth 258 4961
Tear, Rip or Hole in Device Packaging 225 226
Break 221 222
Loss of Osseointegration 164 243
Unstable 161 163
Manufacturing, Packaging or Shipping Problem 152 152
Detachment of Device or Device Component 146 150
Noise, Audible 133 142
Patient Device Interaction Problem 124 129
Packaging Problem 118 118
Difficult to Insert 113 114
Appropriate Device Problem Term/Code Not Available 106 107
Delivered as Unsterile Product 102 102
Corroded 86 98
Degraded 79 82
Malposition of Device 72 4137
Failure to Osseointegrate 63 63
Use of Device Problem 51 51
Device Contaminated During Manufacture or Shipping 50 50
Mechanical Problem 50 51
Patient-Device Incompatibility 46 46
Material Integrity Problem 43 47
No Apparent Adverse Event 39 40
Crack 37 37
Improper or Incorrect Procedure or Method 33 2136
Inadequacy of Device Shape and/or Size 32 32
Implant subsidence 32 367
Biocompatibility 31 32
Positioning Failure 30 30
Off-Label Use 29 29
Unintended Movement 26 26
Device-Device Incompatibility 25 25
Positioning Problem 24 24
Loss of or Failure to Bond 22 23
Migration or Expulsion of Device 19 21
Inaccurate Information 18 18
Wrong Label 18 18
Separation Failure 18 18
Difficult to Remove 17 18
Device Damaged Prior to Use 17 17
Mechanical Jam 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2340 8768
Joint Dislocation 2186 8869
Pain 2110 5464
No Clinical Signs, Symptoms or Conditions 1751 2173
Insufficient Information 1516 8550
Failure of Implant 934 1037
Inadequate Osseointegration 733 754
Joint Laxity 725 2250
Bone Fracture(s) 694 1888
Metal Related Pathology 529 2243
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 404 411
Medical device site infection 379 513
Fall 363 372
Osteolysis 329 3496
Limb Fracture 326 328
Ambulation or Postural Difficulties 295 313
Implant Pain 214 245
Foreign Body Reaction 211 233
Aseptic loosening 188 6732
Loss of Range of Motion 172 202
Unequal Limb Length 153 1448
Swelling/ Edema 147 161
Periprosthetic fracture 139 6517
Physical Asymmetry 131 136
High metal ion levels 120 122
Hematoma 110 138
Discomfort 105 110
Inflammation 105 108
Extraskeletal ossification 99 374
Unspecified Tissue Injury 92 99
Fluid Discharge 89 90
Muscle/Tendon Damage 86 97
Scar Tissue 86 96
Hypersensitivity/Allergic reaction 83 94
Bacterial Infection 77 80
Thrombosis/Thrombus 71 73
Synovitis 71 80
Necrosis 67 73
Hip Fracture 64 68
Bursitis 60 60
Post Operative Wound Infection 55 103
Wound Dehiscence 53 55
Joint Impingement 51 98
Hemorrhage/Blood Loss/Bleeding 47 53
Subluxation 46 55
Foreign Body In Patient 46 50
Nerve Damage 46 50
Osteopenia/ Osteoporosis 37 41
Erythema 36 37
Adhesion(s) 35 41

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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