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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 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
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 5225 5225
2023 5375 5412
2024 5683 5683

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12169 12191
Device Dislodged or Dislocated 5053 5068
Naturally Worn 1531 1531
Fracture 1504 1504
Insufficient Information 1380 1380
Osseointegration Problem 1039 1039
Material Erosion 932 932
Degraded 725 725
Difficult to Insert 628 628
Corroded 570 570
Appropriate Term/Code Not Available 548 548
Migration 529 529
Loss of Osseointegration 517 517
Detachment of Device or Device Component 478 478
Loosening of Implant Not Related to Bone-Ingrowth 395 395
Unstable 393 393
Noise, Audible 353 353
Use of Device Problem 300 300
Device Contaminated During Manufacture or Shipping 292 292
Malposition of Device 291 291
Device-Device Incompatibility 177 177
Loss of or Failure to Bond 166 166
Packaging Problem 155 155
Manufacturing, Packaging or Shipping Problem 135 135
Break 129 129
Patient Device Interaction Problem 110 110
Positioning Failure 97 97
Unintended Movement 95 95
Difficult to Remove 85 85
Off-Label Use 80 80
Tear, Rip or Hole in Device Packaging 73 73
Separation Failure 72 72
Material Deformation 63 63
Loose or Intermittent Connection 63 63
Device Appears to Trigger Rejection 59 59
Positioning Problem 56 56
No Apparent Adverse Event 51 51
Failure to Osseointegrate 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 26 26
Biocompatibility 25 25
Defective Device 19 19
Patient-Device Incompatibility 18 18
Difficult to Advance 18 18
Material Integrity Problem 18 18
Device Difficult to Setup or Prepare 18 18
Activation, Positioning or Separation Problem 17 17
Delivered as Unsterile Product 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6708 6708
Unspecified Infection 4265 4287
Joint Dislocation 4068 4083
Insufficient Information 3181 3181
No Code Available 2249 2249
Joint Laxity 1935 1935
Foreign Body Reaction 1901 1901
Metal Related Pathology 1863 1863
No Clinical Signs, Symptoms or Conditions 1645 1645
Inadequate Osseointegration 1536 1536
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1487 1487
Ambulation Difficulties 1162 1162
Bone Fracture(s) 1017 1017
Osteolysis 999 999
Failure of Implant 996 996
Fall 866 866
Injury 843 843
Inflammation 798 798
Swelling/ Edema 700 700
Unspecified Tissue Injury 661 661
Loss of Range of Motion 656 656
Discomfort 653 653
Hypersensitivity/Allergic reaction 620 620
Limb Fracture 602 602
Necrosis 423 423
Scar Tissue 368 368
No Information 366 366
Reaction 353 353
Adhesion(s) 339 339
Distress 333 333
Ossification 325 325
Muscle/Tendon Damage 311 311
Hematoma 304 304
Physical Asymmetry 277 277
No Known Impact Or Consequence To Patient 274 274
Synovitis 269 269
Fatigue 250 250
Test Result 199 199
Tissue Damage 188 188
Fluid Discharge 177 177
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
Cyst(s) 157 157
Thrombosis/Thrombus 156 156
Local Reaction 146 146
Edema 137 137
Osteopenia/ Osteoporosis 131 131

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
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