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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/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 5
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
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION CASTING SOLUTION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
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 7125 7125
2020 5425 5425
2021 5981 5981
2022 5224 5224
2023 5377 5414
2024 4250 4250

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13735 13757
Device Dislodged or Dislocated 6067 6082
Insufficient Information 2267 2267
Naturally Worn 1749 1749
Fracture 1687 1687
Osseointegration Problem 1442 1442
Loss of Osseointegration 1254 1254
Material Erosion 1165 1165
Corroded 907 907
Degraded 859 859
Appropriate Term/Code Not Available 695 695
Difficult to Insert 664 664
Migration 646 646
Detachment of Device or Device Component 511 511
Unstable 469 469
Malposition of Device 423 423
Noise, Audible 411 411
Loosening of Implant Not Related to Bone-Ingrowth 394 394
Use of Device Problem 363 363
Device Contaminated During Manufacture or Shipping 333 333
Biocompatibility 273 273
Device-Device Incompatibility 205 205
Packaging Problem 205 205
Break 191 191
Loss of or Failure to Bond 187 187
Loose or Intermittent Connection 140 140
Difficult to Remove 129 129
Unintended Movement 127 127
Positioning Failure 115 115
Patient Device Interaction Problem 114 114
Manufacturing, Packaging or Shipping Problem 114 114
Positioning Problem 87 87
Tear, Rip or Hole in Device Packaging 85 85
Separation Failure 85 85
Material Deformation 79 79
Off-Label Use 75 75
No Apparent Adverse Event 74 74
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
Component Misassembled 24 24
Improper or Incorrect Procedure or Method 24 24
Device Difficult to Setup or Prepare 24 24
Fitting Problem 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8938 8938
No Code Available 5353 5353
Unspecified Infection 5239 5261
Joint Dislocation 4843 4858
Insufficient Information 2967 2967
Inadequate Osseointegration 2449 2449
Foreign Body Reaction 2269 2269
Injury 2030 2030
Metal Related Pathology 1888 1888
Joint Laxity 1828 1828
No Clinical Signs, Symptoms or Conditions 1549 1549
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1494 1494
Inflammation 1314 1314
Ambulation Difficulties 1288 1288
Discomfort 1287 1287
Bone Fracture(s) 1256 1256
Osteolysis 1225 1225
Tissue Damage 1155 1155
Failure of Implant 989 989
Test Result 939 939
Fall 917 917
Hypersensitivity/Allergic reaction 828 828
Loss of Range of Motion 777 777
Reaction 754 754
Swelling/ Edema 705 705
Unspecified Tissue Injury 697 697
No Information 681 681
Necrosis 598 598
Limb Fracture 571 571
Limited Mobility Of The Implanted Joint 567 567
No Known Impact Or Consequence To Patient 489 489
Scar Tissue 453 453
Adhesion(s) 396 396
Hematoma 372 372
Ossification 369 369
Distress 352 352
Muscle/Tendon Damage 318 318
Synovitis 311 311
Local Reaction 307 307
Fatigue 281 281
No Consequences Or Impact To Patient 280 280
Physical Asymmetry 277 277
Host-Tissue Reaction 269 269
Swelling 261 261
No Patient Involvement 256 256
Edema 238 238
Hemorrhage/Bleeding 205 205
Cyst(s) 201 201
Pulmonary Embolism 200 200
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
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