• 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/polymer, porous uncemented
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product CodeLPH
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
ADLER ORTHO S.P.A
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCORE9, LLC.
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTERNATIONAL, LTD
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 6
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP. (AKA STRYKER ORTHOPAEDICS)
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. A.K.A. STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
THEKEN COMPANIES
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5425 5425
2021 5979 5979
2022 5224 5224
2023 5375 5412
2024 5678 5678
2025 489 489

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12401 12423
Device Dislodged or Dislocated 5149 5164
Naturally Worn 1556 1556
Fracture 1536 1536
Insufficient Information 1385 1385
Osseointegration Problem 1067 1067
Material Erosion 935 935
Degraded 732 732
Difficult to Insert 638 638
Corroded 580 580
Appropriate Term/Code Not Available 548 548
Migration 534 534
Loss of Osseointegration 519 519
Detachment of Device or Device Component 485 485
Loosening of Implant Not Related to Bone-Ingrowth 401 401
Unstable 400 400
Noise, Audible 355 355
Use of Device Problem 300 300
Device Contaminated During Manufacture or Shipping 293 293
Malposition of Device 291 291
Device-Device Incompatibility 178 178
Loss of or Failure to Bond 171 171
Packaging Problem 156 156
Manufacturing, Packaging or Shipping Problem 142 142
Break 129 129
Patient Device Interaction Problem 111 111
Positioning Failure 98 98
Unintended Movement 96 96
Difficult to Remove 86 86
Off-Label Use 80 80
Tear, Rip or Hole in Device Packaging 73 73
Separation Failure 72 72
Loose or Intermittent Connection 63 63
Material Deformation 63 63
Device Appears to Trigger Rejection 60 60
Positioning Problem 56 56
Failure to Osseointegrate 51 51
No Apparent Adverse Event 51 51
Inadequacy of Device Shape and/or Size 39 39
Mechanical Problem 32 32
Migration or Expulsion of Device 31 31
Improper or Incorrect Procedure or Method 28 28
Biocompatibility 26 26
Difficult to Advance 20 20
Material Integrity Problem 19 19
Defective Device 19 19
Delivered as Unsterile Product 19 19
Patient-Device Incompatibility 18 18
Device Difficult to Setup or Prepare 18 18
Material Twisted/Bent 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6799 6799
Unspecified Infection 4358 4380
Joint Dislocation 4154 4169
Insufficient Information 3262 3262
No Code Available 2249 2249
Joint Laxity 1983 1983
Foreign Body Reaction 1914 1914
Metal Related Pathology 1883 1883
No Clinical Signs, Symptoms or Conditions 1670 1670
Inadequate Osseointegration 1564 1564
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1489 1489
Ambulation Difficulties 1179 1179
Bone Fracture(s) 1032 1032
Failure of Implant 1017 1017
Osteolysis 1005 1005
Fall 884 884
Injury 843 843
Inflammation 802 802
Swelling/ Edema 708 708
Unspecified Tissue Injury 666 666
Loss of Range of Motion 661 661
Discomfort 657 657
Hypersensitivity/Allergic reaction 627 627
Limb Fracture 613 613
Necrosis 423 423
Scar Tissue 372 372
No Information 366 366
Reaction 353 353
Adhesion(s) 339 339
Distress 336 336
Ossification 331 331
Muscle/Tendon Damage 313 313
Hematoma 306 306
Physical Asymmetry 278 278
No Known Impact Or Consequence To Patient 274 274
Synovitis 273 273
Fatigue 255 255
Test Result 199 199
Tissue Damage 188 188
Fluid Discharge 186 186
No Patient Involvement 176 176
Limited Mobility Of The Implanted Joint 175 175
Hemorrhage/Bleeding 166 166
Nerve Damage 158 158
Muscular Rigidity 158 158
Thrombosis/Thrombus 156 156
Cyst(s) 156 156
Local Reaction 146 146
Edema 137 137
Osteopenia/ Osteoporosis 132 132

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-23-2023
2 Biomet, Inc. II Dec-17-2020
3 Conformis, Inc. II Nov-20-2020
4 Encore Medical, LP II Oct-12-2023
5 Encore Medical, LP II Oct-21-2022
6 Encore Medical, LP II Oct-20-2020
7 Encore Medical, LP II May-08-2020
8 Encore Medical, LP II Apr-10-2020
9 Exactech, Inc. II Jan-18-2024
10 Exactech, Inc. II Sep-09-2022
11 Exactech, Inc. II Jul-22-2021
12 Howmedica Osteonics Corp. II Apr-25-2024
13 Howmedica Osteonics Corp. II Feb-16-2022
14 Howmedica Osteonics Corp. II May-07-2020
15 Limacorporate S.p.A II Oct-21-2021
16 Novosource, LLC II Nov-18-2024
17 OmniLife Science II Nov-16-2021
18 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-26-2023
19 Zimmer Biomet, Inc. II Oct-06-2020
20 Zimmer, Inc. II Mar-29-2023
-
-