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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 4
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 5
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 2

MDR Year MDR Reports MDR Events
2020 1963 1972
2021 2199 2199
2022 1985 1988
2023 2064 2092
2024 2586 2901
2025 2773 4324

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5306 6090
Device Dislodged or Dislocated 2179 2485
Fracture 987 988
Appropriate Term/Code Not Available 802 803
Insufficient Information 698 712
Osseointegration Problem 571 584
Naturally Worn 413 483
Break 310 310
Loosening of Implant Not Related to Bone-Ingrowth 296 460
Material Erosion 294 363
Device Appears to Trigger Rejection 264 264
Migration 255 398
Unstable 172 172
Tear, Rip or Hole in Device Packaging 167 167
Manufacturing, Packaging or Shipping Problem 163 163
Loose or Intermittent Connection 159 159
Loss of Osseointegration 158 236
Noise, Audible 146 149
Patient Device Interaction Problem 132 132
Corroded 126 130
Detachment of Device or Device Component 125 125
Packaging Problem 120 120
Difficult to Insert 113 113
Failure to Osseointegrate 71 71
Inadequacy of Device Shape and/or Size 69 69
Degraded 69 69
Malposition of Device 67 100
Delivered as Unsterile Product 66 66
Use of Device Problem 55 55
Patient-Device Incompatibility 52 52
Device Contaminated During Manufacture or Shipping 51 51
Mechanical Problem 49 49
No Apparent Adverse Event 43 43
Crack 42 42
Unintended Movement 42 42
Material Integrity Problem 41 41
Positioning Problem 32 32
Biocompatibility 31 31
Positioning Failure 28 28
Off-Label Use 28 28
Device-Device Incompatibility 27 27
Improper or Incorrect Procedure or Method 26 26
Migration or Expulsion of Device 26 26
Difficult to Remove 25 25
Scratched Material 23 23
Separation Failure 23 23
Device Damaged Prior to Use 22 22
Mechanical Jam 21 21
Inaccurate Information 20 20
Loss of or Failure to Bond 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2268 2373
Joint Dislocation 2224 2560
Pain 2169 2327
No Clinical Signs, Symptoms or Conditions 1577 1959
Insufficient Information 1285 1512
Failure of Implant 1008 1066
Inadequate Osseointegration 706 721
Bone Fracture(s) 678 722
No Code Available 611 612
Joint Laxity 599 616
Metal Related Pathology 474 648
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 434 437
Fall 370 370
Osteolysis 289 338
Limb Fracture 279 279
Ambulation Difficulties 267 267
Foreign Body Reaction 207 207
Loss of Range of Motion 171 178
Implant Pain 171 199
No Known Impact Or Consequence To Patient 136 136
Swelling/ Edema 132 132
No Information 124 124
Inflammation 119 119
Unequal Limb Length 117 117
Discomfort 116 116
Physical Asymmetry 114 114
Hematoma 104 105
Injury 97 97
Ossification 88 95
Unspecified Tissue Injury 87 87
Hip Fracture 87 87
Hypersensitivity/Allergic reaction 86 87
Scar Tissue 84 85
Bacterial Infection 78 78
Joint Disorder 76 76
Muscle/Tendon Damage 76 76
Fluid Discharge 75 75
Necrosis 75 75
Thrombosis/Thrombus 64 64
Synovitis 62 63
No Consequences Or Impact To Patient 57 57
Hemorrhage/Bleeding 47 47
Wound Dehiscence 47 49
Post Operative Wound Infection 46 94
Subluxation 45 51
Adhesion(s) 45 45
Local Reaction 41 41
Foreign Body In Patient 41 41
Fatigue 39 41
Osteopenia/ Osteoporosis 38 38

Recalls
Manufacturer Recall Class Date Posted
1 BioPro, Inc. II Oct-14-2025
2 Biomet, Inc. II Dec-18-2023
3 Biomet, Inc. II May-28-2020
4 Corin Ltd II Dec-19-2022
5 Encore Medical, LP II Sep-19-2023
6 Exactech, Inc. II Sep-09-2022
7 Exactech, Inc. II Aug-12-2021
8 Exactech, Inc. II Jul-22-2021
9 Howmedica Osteonics Corp. II Mar-31-2022
10 IMPLANTCAST GMBH II Jul-09-2021
11 OMNIlife science Inc. II Jan-26-2021
12 Smith & Nephew Inc II May-24-2024
13 Smith & Nephew Orthopaedics AG II Aug-19-2020
14 Waldemar Link GmbH & Co. KG (Mfg Site) II Dec-26-2024
15 Waldemar Link GmbH & Co. KG (Mfg Site) II Feb-29-2024
16 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-04-2023
17 Zimmer GmbH II Sep-12-2024
18 Zimmer, Inc. II Apr-21-2025
19 Zimmer, Inc. II Mar-24-2025
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