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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, cemented
Regulation Description Hip joint metal/polymer semi-constrained cemented prosthesis.
Product CodeJDI
Regulation Number 888.3350
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 4014 4014
2021 3172 3172
2022 1979 1979
2023 1653 1798
2024 1823 1823
2025 129 129

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4825 4875
Device Dislodged or Dislocated 1872 1872
Naturally Worn 1425 1425
Insufficient Information 997 1077
Fracture 565 585
Break 468 468
Degraded 448 448
Loosening of Implant Not Related to Bone-Ingrowth 391 394
Detachment of Device or Device Component 369 373
Material Erosion 356 356
Corroded 331 331
Appropriate Term/Code Not Available 213 213
Osseointegration Problem 198 198
Unstable 181 181
Migration 179 185
Loss of Osseointegration 150 150
Difficult to Insert 146 146
Noise, Audible 120 120
Loss of or Failure to Bond 98 98
Use of Device Problem 92 92
Material Deformation 90 90
Material Twisted/Bent 89 89
Device Contaminated During Manufacture or Shipping 82 82
Loose or Intermittent Connection 78 78
Packaging Problem 78 78
Patient Device Interaction Problem 70 70
Malposition of Device 69 69
Connection Problem 65 65
Positioning Failure 55 55
Unintended Movement 49 49
Incomplete or Inadequate Connection 42 42
Mechanical Problem 40 42
Tear, Rip or Hole in Device Packaging 34 34
Difficult to Remove 32 32
Off-Label Use 32 32
Mechanical Jam 28 28
Crack 27 27
Material Fragmentation 27 27
Defective Device 27 27
Device Appears to Trigger Rejection 26 26
Physical Resistance/Sticking 26 26
Device-Device Incompatibility 24 24
Biocompatibility 23 23
Inadequacy of Device Shape and/or Size 23 23
Failure to Osseointegrate 22 22
Fitting Problem 22 22
Manufacturing, Packaging or Shipping Problem 21 21
No Apparent Adverse Event 20 20
Migration or Expulsion of Device 17 21
Premature Separation 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 2818 2818
No Code Available 1743 1743
Joint Dislocation 1720 1720
Insufficient Information 1301 1301
Unspecified Infection 1287 1296
Failure of Implant 1254 1349
No Clinical Signs, Symptoms or Conditions 1208 1208
Foreign Body Reaction 1046 1046
Osteolysis 783 783
Metal Related Pathology 707 707
Ambulation Difficulties 594 594
Joint Laxity 568 568
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 566 566
Bone Fracture(s) 505 519
Injury 450 450
Inflammation 424 424
Inadequate Osseointegration 375 375
Hypersensitivity/Allergic reaction 344 344
No Information 330 330
Test Result 306 306
Swelling/ Edema 282 282
Discomfort 273 273
Fall 270 270
Loss of Range of Motion 217 217
Reaction 211 211
No Known Impact Or Consequence To Patient 180 180
No Consequences Or Impact To Patient 170 170
Unspecified Tissue Injury 169 169
Synovitis 166 166
Adhesion(s) 146 146
Necrosis 144 144
Edema 129 129
No Patient Involvement 122 122
Scar Tissue 121 140
Implant Pain 119 119
Hematoma 109 109
Ossification 104 104
Limited Mobility Of The Implanted Joint 100 100
Physical Asymmetry 94 94
Tissue Damage 94 94
Hemorrhage/Bleeding 78 78
Fatigue 75 75
Distress 73 73
Cyst(s) 71 71
Hip Fracture 70 70
Osteopenia/ Osteoporosis 69 69
Nerve Damage 65 65
Fluid Discharge 64 64
Wound Dehiscence 60 60
Bacterial Infection 60 60

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jun-25-2024
2 Biomet, Inc. II Dec-17-2020
3 Biomet, Inc. II Oct-09-2020
4 Biomet, Inc. II May-28-2020
5 Corin Ltd II Aug-31-2022
6 Corin Ltd II Aug-09-2022
7 DePuy Orthopaedics, Inc. II Jun-10-2021
8 Exactech, Inc. II Sep-09-2022
9 Howmedica Osteonics Corp. II Aug-26-2024
10 Howmedica Osteonics Corp. II Jan-15-2020
11 MicroPort Orthopedics Inc. II Jun-02-2022
12 Zimmer Biomet, Inc. II Nov-02-2020
13 Zimmer, Inc. II Jul-30-2024
14 Zimmer, Inc. II Sep-07-2023
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