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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
  1.  K233498  Stryker Orthopaedics Hip Systems Labeling Update
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 2
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 5225 5225
2023 5375 5412
2024 5199 5199

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14197 14219
Device Dislodged or Dislocated 6242 6257
Insufficient Information 2296 2296
Naturally Worn 1778 1778
Fracture 1756 1756
Osseointegration Problem 1474 1474
Loss of Osseointegration 1260 1260
Material Erosion 1189 1189
Corroded 916 916
Degraded 873 873
Appropriate Term/Code Not Available 696 696
Difficult to Insert 684 684
Migration 658 658
Detachment of Device or Device Component 520 520
Unstable 474 474
Malposition of Device 433 433
Noise, Audible 418 418
Loosening of Implant Not Related to Bone-Ingrowth 409 409
Use of Device Problem 371 371
Device Contaminated During Manufacture or Shipping 334 334
Biocompatibility 273 273
Packaging Problem 214 214
Device-Device Incompatibility 211 211
Loss of or Failure to Bond 194 194
Break 191 191
Loose or Intermittent Connection 140 140
Difficult to Remove 130 130
Unintended Movement 127 127
Manufacturing, Packaging or Shipping Problem 124 124
Positioning Failure 117 117
Patient Device Interaction Problem 116 116
Separation Failure 89 89
Positioning Problem 88 88
Tear, Rip or Hole in Device Packaging 86 86
Material Deformation 84 84
Off-Label Use 82 82
No Apparent Adverse Event 75 75
Failure to Osseointegrate 68 68
Migration or Expulsion of Device 60 60
Device Appears to Trigger Rejection 58 58
Inadequacy of Device Shape and/or Size 55 55
Mechanical Problem 55 55
Nonstandard Device 38 38
Patient-Device Incompatibility 32 32
Separation Problem 27 27
Improper or Incorrect Procedure or Method 25 25
Difficult or Delayed Separation 25 25
Device Difficult to Setup or Prepare 24 24
Material Integrity Problem 24 24
Fitting Problem 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 9117 9117
Unspecified Infection 5428 5450
No Code Available 5352 5352
Joint Dislocation 4996 5011
Insufficient Information 3143 3143
Inadequate Osseointegration 2487 2487
Foreign Body Reaction 2312 2312
Injury 2031 2031
Metal Related Pathology 1945 1945
Joint Laxity 1897 1897
No Clinical Signs, Symptoms or Conditions 1615 1615
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1497 1497
Inflammation 1327 1327
Ambulation Difficulties 1312 1312
Discomfort 1299 1299
Bone Fracture(s) 1280 1280
Osteolysis 1243 1243
Tissue Damage 1155 1155
Failure of Implant 1025 1025
Fall 943 943
Test Result 939 939
Hypersensitivity/Allergic reaction 837 837
Loss of Range of Motion 791 791
Reaction 754 754
Swelling/ Edema 726 726
Unspecified Tissue Injury 700 700
No Information 681 681
Necrosis 606 606
Limb Fracture 596 596
Limited Mobility Of The Implanted Joint 567 567
No Known Impact Or Consequence To Patient 489 489
Scar Tissue 457 457
Adhesion(s) 398 398
Ossification 381 381
Hematoma 374 374
Distress 352 352
Muscle/Tendon Damage 320 320
Synovitis 311 311
Local Reaction 307 307
Fatigue 281 281
Physical Asymmetry 280 280
No Consequences Or Impact To Patient 280 280
Host-Tissue Reaction 269 269
Swelling 261 261
No Patient Involvement 256 256
Edema 238 238
Pulmonary Embolism 205 205
Hemorrhage/Bleeding 205 205
Cyst(s) 203 203
Fluid Discharge 182 182

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 Novosource, LLC II Nov-18-2024
21 OMNIlife science Inc. II Oct-21-2019
22 OMNIlife science Inc. II Sep-05-2019
23 OmniLife Science II Nov-16-2021
24 Smith & Nephew, Inc. II Mar-20-2019
25 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-26-2023
26 Zimmer Biomet, Inc. II Oct-06-2020
27 Zimmer Biomet, Inc. II Nov-22-2019
28 Zimmer Biomet, Inc. II Nov-07-2019
29 Zimmer, Inc. II Mar-29-2023
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