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/polymer, porous uncemented
Product CodeLPH
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCORE9, LLC.
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORENTEC CO., LTD
  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 4
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. (AKA STRYKER ORTHOPAEDICS)
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. A.K.A. STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. AKA 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 2
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC ADVANCED ENERGY
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION CASTING SOLUTION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
STELKAST, INC.
  SUBSTANTIALLY EQUIVALENT 1
THECKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
THEKEN COMPANIES
  SUBSTANTIALLY EQUIVALENT 1
THEKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 7118 7118
2020 5425 5425
2021 5983 5983
2022 5224 5224
2023 5378 5415
2024 3810 3810

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13488 13510
Device Dislodged or Dislocated 5983 5998
Insufficient Information 2244 2244
Naturally Worn 1731 1731
Fracture 1673 1673
Osseointegration Problem 1436 1436
Loss of Osseointegration 1252 1252
Material Erosion 1155 1155
Corroded 901 901
Degraded 838 838
Appropriate Term/Code Not Available 694 694
Difficult to Insert 663 663
Migration 636 636
Detachment of Device or Device Component 503 503
Unstable 466 466
Malposition of Device 420 420
Noise, Audible 409 409
Loosening of Implant Not Related to Bone-Ingrowth 392 392
Use of Device Problem 362 362
Device Contaminated During Manufacture or Shipping 332 332
Biocompatibility 273 273
Device-Device Incompatibility 206 206
Packaging Problem 200 200
Break 192 192
Loss of or Failure to Bond 186 186
Loose or Intermittent Connection 140 140
Difficult to Remove 129 129
Unintended Movement 125 125
Positioning Failure 115 115
Patient Device Interaction Problem 112 112
Manufacturing, Packaging or Shipping Problem 109 109
Positioning Problem 87 87
Tear, Rip or Hole in Device Packaging 85 85
Separation Failure 85 85
Material Deformation 79 79
No Apparent Adverse Event 74 74
Off-Label Use 73 73
Failure to Osseointegrate 68 68
Migration or Expulsion of Device 60 60
Device Appears to Trigger Rejection 56 56
Mechanical Problem 55 55
Inadequacy of Device Shape and/or Size 52 52
Nonstandard Device 38 38
Patient-Device Incompatibility 32 32
Separation Problem 27 27
Difficult or Delayed Separation 24 24
Device Difficult to Setup or Prepare 24 24
Fitting Problem 24 24
Component Misassembled 24 24
Improper or Incorrect Procedure or Method 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8848 8848
No Code Available 5353 5353
Unspecified Infection 5152 5174
Joint Dislocation 4762 4777
Insufficient Information 2901 2901
Inadequate Osseointegration 2438 2438
Foreign Body Reaction 2250 2250
Injury 2022 2022
Metal Related Pathology 1845 1845
Joint Laxity 1798 1798
No Clinical Signs, Symptoms or Conditions 1529 1529
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1493 1493
Inflammation 1305 1305
Ambulation Difficulties 1283 1283
Discomfort 1281 1281
Bone Fracture(s) 1237 1237
Osteolysis 1210 1210
Tissue Damage 1155 1155
Failure of Implant 972 972
Test Result 939 939
Fall 908 908
Hypersensitivity/Allergic reaction 826 826
Loss of Range of Motion 778 778
Reaction 750 750
Swelling/ Edema 701 701
Unspecified Tissue Injury 694 694
No Information 681 681
Necrosis 597 597
Limited Mobility Of The Implanted Joint 567 567
Limb Fracture 564 564
No Known Impact Or Consequence To Patient 489 489
Scar Tissue 451 451
Adhesion(s) 389 389
Hematoma 371 371
Ossification 365 365
Distress 354 354
Muscle/Tendon Damage 318 318
Local Reaction 307 307
Synovitis 303 303
Fatigue 281 281
No Consequences Or Impact To Patient 280 280
Physical Asymmetry 278 278
Host-Tissue Reaction 269 269
Swelling 261 261
No Patient Involvement 256 256
Edema 238 238
Hemorrhage/Bleeding 204 204
Cyst(s) 199 199
Pulmonary Embolism 193 193
Nerve Damage 171 171

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 Conformis, Inc. II Oct-08-2019
5 Conformis, Inc. II Jun-13-2019
6 Conformis, Inc. II Jan-12-2019
7 Encore Medical, LP II Oct-12-2023
8 Encore Medical, LP II Oct-21-2022
9 Encore Medical, LP II Oct-20-2020
10 Encore Medical, LP II May-08-2020
11 Encore Medical, LP II Apr-10-2020
12 Exactech, Inc. II Jan-18-2024
13 Exactech, Inc. II Sep-09-2022
14 Exactech, Inc. II Jul-22-2021
15 Howmedica Osteonics Corp. II Apr-25-2024
16 Howmedica Osteonics Corp. II Feb-16-2022
17 Howmedica Osteonics Corp. II May-07-2020
18 Howmedica Osteonics Corp. II Nov-22-2019
19 Limacorporate S.p.A II Oct-21-2021
20 OMNIlife science Inc. II Oct-21-2019
21 OMNIlife science Inc. II Sep-05-2019
22 OmniLife Science II Nov-16-2021
23 Smith & Nephew, Inc. II Mar-20-2019
24 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-26-2023
25 Zimmer Biomet, Inc. II Oct-06-2020
26 Zimmer Biomet, Inc. II Nov-22-2019
27 Zimmer Biomet, Inc. II Nov-07-2019
28 Zimmer, Inc. II Mar-29-2023
-
-