Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
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
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 S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
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 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 2075 2100
2024 2585 2900

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3997 4117
Device Dislodged or Dislocated 1762 1768
Fracture 821 822
Appropriate Term/Code Not Available 792 792
Insufficient Information 581 594
Osseointegration Problem 500 513
Naturally Worn 392 462
Break 296 296
Loosening of Implant Not Related to Bone-Ingrowth 241 265
Migration 217 360
Material Erosion 187 187
Device Appears to Trigger Rejection 185 185
Loose or Intermittent Connection 159 159
Unstable 153 153
Loss of Osseointegration 123 123
Noise, Audible 122 122
Patient Device Interaction Problem 119 119
Corroded 117 117
Manufacturing, Packaging or Shipping Problem 101 101
Detachment of Device or Device Component 97 97
Difficult to Insert 86 86
Tear, Rip or Hole in Device Packaging 83 83
Packaging Problem 70 70
Failure to Osseointegrate 62 62
Degraded 62 62
Inadequacy of Device Shape and/or Size 60 60
Malposition of Device 53 53
Use of Device Problem 52 52
Device Contaminated During Manufacture or Shipping 44 44
Mechanical Problem 43 43
Unintended Movement 42 42
Crack 41 41
Material Integrity Problem 39 39
No Apparent Adverse Event 37 37
Patient-Device Incompatibility 36 36
Biocompatibility 30 30
Delivered as Unsterile Product 27 27
Positioning Problem 27 27
Migration or Expulsion of Device 25 25
Improper or Incorrect Procedure or Method 24 24
Difficult to Remove 24 24
Scratched Material 23 23
Off-Label Use 22 22
Positioning Failure 22 22
Device-Device Incompatibility 21 21
Inaccurate Information 20 20
Mechanical Jam 18 18
Device Damaged Prior to Use 18 18
Wrong Label 17 17
Loss of or Failure to Bond 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1821 1889
Unspecified Infection 1772 1816
Joint Dislocation 1752 1771
No Clinical Signs, Symptoms or Conditions 1143 1187
Insufficient Information 994 1113
Failure of Implant 879 934
Inadequate Osseointegration 620 633
No Code Available 611 611
Bone Fracture(s) 546 567
Joint Laxity 485 485
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 414 414
Metal Related Pathology 341 341
Fall 314 314
Osteolysis 230 278
Ambulation Difficulties 214 214
Limb Fracture 210 210
Foreign Body Reaction 191 191
Loss of Range of Motion 148 148
Implant Pain 138 138
No Known Impact Or Consequence To Patient 136 136
No Information 124 124
Swelling/ Edema 107 107
Discomfort 102 102
Inflammation 98 98
Injury 97 97
Physical Asymmetry 94 94
Unequal Limb Length 84 84
Hip Fracture 84 84
Hematoma 81 81
Unspecified Tissue Injury 76 76
Joint Disorder 76 76
Ossification 75 75
Bacterial Infection 68 68
Hypersensitivity/Allergic reaction 66 66
Muscle/Tendon Damage 65 65
Necrosis 64 64
Fluid Discharge 64 64
Scar Tissue 64 64
No Consequences Or Impact To Patient 57 57
Synovitis 49 49
Adhesion(s) 45 45
Thrombosis/Thrombus 41 41
Hemorrhage/Bleeding 39 39
Fatigue 38 38
Local Reaction 37 37
Wound Dehiscence 37 37
Osteopenia/ Osteoporosis 36 36
Tissue Damage 35 35
Limited Mobility Of The Implanted Joint 33 33
Erythema 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
-
-