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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
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 2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 5675 5675
2025 1278 1776

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12713 12843
Device Dislodged or Dislocated 5336 5741
Naturally Worn 1589 1589
Fracture 1585 1585
Insufficient Information 1411 1411
Osseointegration Problem 1087 1087
Material Erosion 953 953
Degraded 756 756
Difficult to Insert 667 667
Corroded 586 586
Appropriate Term/Code Not Available 549 549
Migration 543 543
Loss of Osseointegration 527 527
Detachment of Device or Device Component 501 501
Loosening of Implant Not Related to Bone-Ingrowth 423 423
Unstable 405 405
Noise, Audible 355 355
Use of Device Problem 307 307
Device Contaminated During Manufacture or Shipping 297 297
Malposition of Device 294 294
Device-Device Incompatibility 179 179
Loss of or Failure to Bond 172 172
Packaging Problem 171 171
Manufacturing, Packaging or Shipping Problem 158 158
Break 129 129
Patient Device Interaction Problem 111 111
Positioning Failure 98 98
Unintended Movement 97 97
Difficult to Remove 87 87
Off-Label Use 83 83
Tear, Rip or Hole in Device Packaging 76 76
Separation Failure 73 73
Material Deformation 69 69
Loose or Intermittent Connection 63 63
Device Appears to Trigger Rejection 62 62
Positioning Problem 59 59
No Apparent Adverse Event 56 56
Failure to Osseointegrate 52 52
Inadequacy of Device Shape and/or Size 41 41
Mechanical Problem 33 33
Migration or Expulsion of Device 31 31
Improper or Incorrect Procedure or Method 31 31
Biocompatibility 26 26
Difficult to Advance 21 21
Delivered as Unsterile Product 20 20
Material Integrity Problem 19 19
Defective Device 19 19
Patient-Device Incompatibility 18 18
Device Difficult to Setup or Prepare 18 18
Activation, Positioning or Separation Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6905 6905
Unspecified Infection 4493 4515
Joint Dislocation 4335 4740
Insufficient Information 3379 3379
No Code Available 2249 2249
Joint Laxity 2020 2020
Foreign Body Reaction 1951 1951
Metal Related Pathology 1929 1929
No Clinical Signs, Symptoms or Conditions 1755 1755
Inadequate Osseointegration 1593 1593
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1493 1493
Ambulation Difficulties 1213 1213
Failure of Implant 1063 1063
Bone Fracture(s) 1045 1045
Osteolysis 1021 1021
Fall 898 898
Injury 843 843
Inflammation 814 814
Swelling/ Edema 720 720
Unspecified Tissue Injury 673 673
Loss of Range of Motion 666 666
Discomfort 662 662
Hypersensitivity/Allergic reaction 635 635
Limb Fracture 624 624
Necrosis 428 428
Scar Tissue 378 378
No Information 366 366
Reaction 353 353
Distress 340 340
Adhesion(s) 339 339
Ossification 336 444
Muscle/Tendon Damage 325 325
Hematoma 310 310
Physical Asymmetry 281 281
No Known Impact Or Consequence To Patient 274 274
Synovitis 273 273
Fatigue 260 260
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
Cyst(s) 160 160
Thrombosis/Thrombus 159 159
Muscular Rigidity 158 158
Nerve Damage 158 158
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 Apr-15-2025
4 Conformis, Inc. II Nov-20-2020
5 Encore Medical, LP II Oct-12-2023
6 Encore Medical, LP II Oct-21-2022
7 Encore Medical, LP II Oct-20-2020
8 Encore Medical, LP II May-08-2020
9 Encore Medical, LP II Apr-10-2020
10 Exactech, Inc. II Feb-12-2025
11 Exactech, Inc. II Jan-18-2024
12 Exactech, Inc. II Sep-09-2022
13 Exactech, Inc. II Jul-22-2021
14 Howmedica Osteonics Corp. II Apr-25-2024
15 Howmedica Osteonics Corp. II Feb-16-2022
16 Howmedica Osteonics Corp. II May-07-2020
17 Limacorporate S.p.A II Oct-21-2021
18 Novosource, LLC II Nov-18-2024
19 OmniLife Science II Nov-16-2021
20 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-26-2023
21 Zimmer Biomet, Inc. II Oct-06-2020
22 Zimmer, Inc. II Mar-29-2023
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