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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
Product CodeJDI
Regulation Number 888.3350
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET MANUFACTURING LLC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 5
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
EXCERA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 2
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
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STANMORE IMPLANTS WORLDWIDE LTD.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH, 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
2014 4946 4946
2015 4893 4893
2016 3992 3992
2017 6138 6138
2018 6736 6736
2019 7406 7406
2020 4015 4015
2021 3171 3171
2022 1980 1980
2023 1653 1798
2024 758 758

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 14291 14371
Adverse Event Without Identified Device or Use Problem 9333 9383
Device Dislodged or Dislocated 6951 6951
Naturally Worn 5009 5009
Appropriate Term/Code Not Available 3701 3701
Fracture 1770 1790
Corroded 1653 1653
Break 1332 1332
Metal Shedding Debris 1157 1157
Loss of Osseointegration 1067 1067
Noise, Audible 933 933
Degraded 774 774
Material Disintegration 678 678
Unstable 617 617
Loose or Intermittent Connection 609 609
Material Erosion 598 598
Migration or Expulsion of Device 528 532
Osseointegration Problem 462 462
Malposition of Device 459 459
Device Operates Differently Than Expected 429 429
Loosening of Implant Not Related to Bone-Ingrowth 406 409
Migration 400 406
Loss of or Failure to Bond 392 392
Detachment of Device or Device Component 390 394
Difficult to Insert 328 328
Device Slipped 295 295
Biocompatibility 276 276
Material Deformation 227 227
Nonstandard Device 226 226
Packaging Problem 205 205
Material Integrity Problem 196 196
Mechanical Problem 180 182
Disassembly 173 173
Use of Device Problem 136 136
Inadequacy of Device Shape and/or Size 127 127
Difficult to Remove 120 120
Device Contaminated During Manufacture or Shipping 106 106
Material Twisted/Bent 97 97
Fitting Problem 95 95
Positioning Problem 92 92
Patient-Device Incompatibility 89 89
Tear, Rip or Hole in Device Packaging 88 88
Crack 87 87
Patient Device Interaction Problem 86 86
Connection Problem 82 82
Failure To Adhere Or Bond 81 81
Unintended Movement 81 81
Detachment Of Device Component 78 78
Device Markings/Labelling Problem 72 72
Device Contamination with Chemical or Other Material 70 70
Positioning Failure 69 69
Device-Device Incompatibility 62 62
Material Fragmentation 59 59
Separation Failure 57 57
No Apparent Adverse Event 56 56
Failure to Osseointegrate 50 50
Difficult To Position 48 48
Compatibility Problem 43 43
Mechanical Jam 42 42
Incomplete or Inadequate Connection 42 42
Material Discolored 42 42
Improper or Incorrect Procedure or Method 39 39
Device Packaging Compromised 38 38
Off-Label Use 38 38
Material Separation 38 38
Defective Device 36 36
Component Missing 31 31
Physical Resistance/Sticking 30 30
Manufacturing, Packaging or Shipping Problem 29 29
Device Inoperable 27 27
Device Appears to Trigger Rejection 27 27
Device Damaged Prior to Use 25 25
Defective Component 24 24
Delivered as Unsterile Product 23 23
Separation Problem 22 22
Scratched Material 21 21
Deformation Due to Compressive Stress 21 21
Device Difficult to Setup or Prepare 20 20
Bent 20 20
Difficult to Open or Remove Packaging Material 18 18
Device Damaged by Another Device 17 17
Premature Separation 17 17
Difficult or Delayed Positioning 16 16
Collapse 15 15
Component Falling 13 13
Unsealed Device Packaging 13 13
Dull, Blunt 12 12
Failure to Align 12 12
Material Protrusion/Extrusion 11 11
Misassembled 10 10
Contamination 10 10
Disconnection 10 10
Entrapment of Device 10 10
Flaked 9 9
Sticking 9 9
Component or Accessory Incompatibility 9 9
Inaccurate Information 9 9
Difficult or Delayed Separation 8 8
Contamination /Decontamination Problem 8 8
Peeled/Delaminated 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 14732 14732
No Code Available 11579 11579
No Information 6260 6260
Unspecified Infection 5031 5040
Joint Dislocation 4678 4678
Injury 4166 4166
Discomfort 4086 4086
Foreign Body Reaction 3602 3602
Inflammation 3294 3294
Host-Tissue Reaction 2212 2212
Test Result 2141 2141
Osteolysis 2034 2034
Tissue Damage 2026 2026
Ambulation Difficulties 1666 1666
Bone Fracture(s) 1625 1639
Reaction 1575 1575
Limited Mobility Of The Implanted Joint 1439 1439
Failure of Implant 1428 1523
No Known Impact Or Consequence To Patient 1374 1374
Not Applicable 1226 1226
No Clinical Signs, Symptoms or Conditions 1162 1162
Inadequate Osseointegration 1055 1055
Loss of Range of Motion 1000 1000
Insufficient Information 999 999
No Consequences Or Impact To Patient 998 998
Hypersensitivity/Allergic reaction 934 934
Metal Related Pathology 741 741
Fall 651 651
Necrosis 587 587
Swelling 575 575
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 526 526
Joint Laxity 488 488
Edema 448 448
Toxicity 393 393
Synovitis 362 362
Joint Disorder 351 351
Distress 339 339
Weakness 337 337
Ossification 306 306
Hematoma 303 303
No Patient Involvement 267 267
Hip Fracture 257 257
Adhesion(s) 253 253
Swelling/ Edema 244 244
Cyst(s) 223 223
Scar Tissue 210 229
Unspecified Tissue Injury 202 202
Muscular Rigidity 196 196
Death 185 185
Fatigue 180 180
Impaired Healing 172 180
Deformity/ Disfigurement 158 158
Wound Dehiscence 155 155
Thrombosis 144 144
Pulmonary Embolism 140 140
Hemorrhage/Bleeding 135 135
Anxiety 132 132
Local Reaction 127 127
Osteopenia/ Osteoporosis 125 125
Blood Loss 123 123
Bacterial Infection 117 117
Nerve Damage 115 115
Joint Swelling 109 109
Fluid Discharge 101 101
Physical Asymmetry 97 97
Complaint, Ill-Defined 95 95
Fever 93 93
Depression 86 86
Hypoesthesia 84 84
Sepsis 73 73
Foreign Body In Patient 69 69
Numbness 68 68
Rash 67 67
Abscess 65 65
Fibrosis 65 65
Implant Pain 62 62
Post Operative Wound Infection 60 60
Erosion 60 60
Device Embedded In Tissue or Plaque 58 58
Headache 55 55
Scarring 55 55
Irritation 55 55
Cardiac Arrest 54 54
Muscle/Tendon Damage 53 53
Myocardial Infarction 51 51
Pocket Erosion 47 47
Cancer 46 46
Unequal Limb Length 43 43
Skin Irritation 43 43
Anemia 43 43
Burning Sensation 42 42
Thrombosis/Thrombus 41 41
Disability 40 40
Erythema 40 40
Seroma 39 39
Renal Failure 38 38
Infarction, Cerebral 38 38
Limb Fracture 38 38
Neuropathy 37 37
Memory Loss/Impairment 33 33

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II Oct-09-2020
3 Biomet, Inc. II May-28-2020
4 Biomet, Inc. III Jun-11-2015
5 Biomet, Inc. II Dec-17-2014
6 Biopro, Inc. II Nov-04-2011
7 Corin Ltd II Aug-31-2022
8 Corin Ltd II Aug-09-2022
9 DePuy Orthopaedics, Inc. II Jun-10-2021
10 DePuy Orthopaedics, Inc. II Jun-29-2012
11 Encore Medical, Lp II Jan-11-2012
12 Exactech, Inc. II Sep-09-2022
13 Exactech, Inc. II Jan-17-2017
14 Howmedica Osteonics Corp. II Jan-15-2020
15 Howmedica Osteonics Corp. II Oct-11-2018
16 Medacta Usa Inc II Nov-08-2012
17 MicroPort Orthopedics Inc. II Jun-02-2022
18 Smith & Nephew Inc II Nov-20-2009
19 Smith & Nephew, Inc. II May-09-2018
20 Smith & Nephew, Inc. II Jan-11-2017
21 Stryker Howmedica Osteonics Corp. II Nov-09-2016
22 Stryker Howmedica Osteonics Corp. II Aug-11-2016
23 Stryker Howmedica Osteonics Corp. II Nov-17-2015
24 Stryker Howmedica Osteonics Corp. II Mar-03-2015
25 Stryker Howmedica Osteonics Corp. II Dec-07-2013
26 Stryker Howmedica Osteonics Corp. II Nov-13-2012
27 Stryker Howmedica Osteonics Corp. II Jul-10-2012
28 Stryker Howmedica Osteonics Corp. II May-13-2010
29 Stryker Howmedica Osteonics Corp. II May-12-2010
30 Stryker Howmedica Osteonics Corp. II Jan-26-2009
31 Zimmer Biomet, Inc. II Nov-02-2020
32 Zimmer Biomet, Inc. II Aug-09-2019
33 Zimmer Biomet, Inc. II Dec-04-2018
34 Zimmer Biomet, Inc. II Aug-14-2018
35 Zimmer Biomet, Inc. II Apr-27-2018
36 Zimmer Biomet, Inc. II Mar-14-2018
37 Zimmer Biomet, Inc. II Mar-14-2018
38 Zimmer Biomet, Inc. II Dec-29-2017
39 Zimmer Biomet, Inc. II Mar-27-2017
40 Zimmer Biomet, Inc. II Feb-22-2016
41 Zimmer Inc. II Jan-25-2012
42 Zimmer Inc. II Sep-27-2011
43 Zimmer Inc. II Jul-23-2009
44 Zimmer Manufacturing B.V. II May-16-2016
45 Zimmer Manufacturing B.V. II Mar-12-2016
46 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
47 Zimmer, Inc. II Sep-07-2023
48 Zimmer, Inc. II Oct-20-2014
49 Zimmer, Inc. II Aug-26-2014
50 Zimmer, Inc. II Feb-20-2014
51 Zimmer, Inc. II Dec-30-2013
52 Zimmer, Inc. II Nov-14-2013
53 Zimmer, Inc. II Oct-25-2013
54 Zimmer, Inc. II Nov-06-2012
55 Zimmer, Inc. II Oct-15-2012
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