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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 2
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 6739 6739
2019 7407 7407
2020 4015 4015
2021 3171 3171
2022 1980 1980
2023 1653 1798
2024 1252 1252

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 14305 14385
Adverse Event Without Identified Device or Use Problem 9482 9532
Device Dislodged or Dislocated 7002 7002
Naturally Worn 5187 5187
Appropriate Term/Code Not Available 3702 3702
Fracture 1783 1803
Corroded 1661 1661
Break 1334 1334
Metal Shedding Debris 1157 1157
Loss of Osseointegration 1069 1069
Noise, Audible 935 935
Degraded 800 800
Material Disintegration 678 678
Material Erosion 625 625
Unstable 620 620
Loose or Intermittent Connection 609 609
Migration or Expulsion of Device 528 532
Osseointegration Problem 470 470
Malposition of Device 460 460
Loosening of Implant Not Related to Bone-Ingrowth 443 446
Device Operates Differently Than Expected 429 429
Migration 410 416
Detachment of Device or Device Component 408 412
Loss of or Failure to Bond 395 395
Difficult to Insert 331 331
Device Slipped 295 295
Biocompatibility 277 277
Material Deformation 227 227
Nonstandard Device 226 226
Packaging Problem 206 206
Material Integrity Problem 196 196
Mechanical Problem 180 182
Disassembly 173 173
Use of Device Problem 142 142
Inadequacy of Device Shape and/or Size 127 127
Difficult to Remove 120 120
Device Contaminated During Manufacture or Shipping 107 107
Material Twisted/Bent 97 97
Fitting Problem 95 95
Positioning Problem 93 93
Tear, Rip or Hole in Device Packaging 90 90
Patient Device Interaction Problem 89 89
Patient-Device Incompatibility 89 89
Crack 88 88
Connection Problem 82 82
Unintended Movement 81 81
Failure To Adhere Or Bond 81 81
Detachment Of Device Component 78 78
Device Markings/Labelling Problem 72 72
Positioning Failure 71 71

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 14837 14837
No Code Available 11579 11579
No Information 6260 6260
Unspecified Infection 5066 5075
Joint Dislocation 4737 4737
Injury 4169 4169
Discomfort 4101 4101
Foreign Body Reaction 3626 3626
Inflammation 3304 3304
Host-Tissue Reaction 2212 2212
Test Result 2141 2141
Osteolysis 2131 2131
Tissue Damage 2026 2026
Ambulation Difficulties 1693 1693
Bone Fracture(s) 1660 1674
Reaction 1577 1577
Failure of Implant 1484 1579
Limited Mobility Of The Implanted Joint 1439 1439
No Known Impact Or Consequence To Patient 1374 1374
Not Applicable 1226 1226
No Clinical Signs, Symptoms or Conditions 1188 1188
Insufficient Information 1105 1105
Inadequate Osseointegration 1068 1068
Loss of Range of Motion 1005 1005
No Consequences Or Impact To Patient 998 998
Hypersensitivity/Allergic reaction 940 940
Metal Related Pathology 792 792
Fall 658 658
Necrosis 591 591
Swelling 575 575
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 567 567
Joint Laxity 527 527
Edema 448 448
Toxicity 393 393
Synovitis 384 384
Joint Disorder 351 351
Distress 340 340
Weakness 337 337
Ossification 309 309
Hematoma 305 305
Swelling/ Edema 278 278
No Patient Involvement 267 267
Hip Fracture 260 260
Adhesion(s) 253 253
Cyst(s) 227 227
Scar Tissue 218 237
Unspecified Tissue Injury 205 205
Muscular Rigidity 196 196
Death 185 185
Fatigue 181 181

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 Biomet, Inc. III Jun-11-2015
6 Biomet, Inc. II Dec-17-2014
7 Biopro, Inc. II Nov-04-2011
8 Corin Ltd II Aug-31-2022
9 Corin Ltd II Aug-09-2022
10 DePuy Orthopaedics, Inc. II Jun-10-2021
11 DePuy Orthopaedics, Inc. II Jun-29-2012
12 Encore Medical, Lp II Jan-11-2012
13 Exactech, Inc. II Sep-09-2022
14 Exactech, Inc. II Jan-17-2017
15 Howmedica Osteonics Corp. II Aug-26-2024
16 Howmedica Osteonics Corp. II Jan-15-2020
17 Howmedica Osteonics Corp. II Oct-11-2018
18 Medacta Usa Inc II Nov-08-2012
19 MicroPort Orthopedics Inc. II Jun-02-2022
20 Smith & Nephew Inc II Nov-20-2009
21 Smith & Nephew, Inc. II May-09-2018
22 Smith & Nephew, Inc. II Jan-11-2017
23 Stryker Howmedica Osteonics Corp. II Nov-09-2016
24 Stryker Howmedica Osteonics Corp. II Aug-11-2016
25 Stryker Howmedica Osteonics Corp. II Nov-17-2015
26 Stryker Howmedica Osteonics Corp. II Mar-03-2015
27 Stryker Howmedica Osteonics Corp. II Dec-07-2013
28 Stryker Howmedica Osteonics Corp. II Nov-13-2012
29 Stryker Howmedica Osteonics Corp. II Jul-10-2012
30 Stryker Howmedica Osteonics Corp. II May-13-2010
31 Stryker Howmedica Osteonics Corp. II May-12-2010
32 Stryker Howmedica Osteonics Corp. II Jan-26-2009
33 Zimmer Biomet, Inc. II Nov-02-2020
34 Zimmer Biomet, Inc. II Aug-09-2019
35 Zimmer Biomet, Inc. II Dec-04-2018
36 Zimmer Biomet, Inc. II Aug-14-2018
37 Zimmer Biomet, Inc. II Apr-27-2018
38 Zimmer Biomet, Inc. II Mar-14-2018
39 Zimmer Biomet, Inc. II Mar-14-2018
40 Zimmer Biomet, Inc. II Dec-29-2017
41 Zimmer Biomet, Inc. II Mar-27-2017
42 Zimmer Biomet, Inc. II Feb-22-2016
43 Zimmer Inc. II Jan-25-2012
44 Zimmer Inc. II Sep-27-2011
45 Zimmer Inc. II Jul-23-2009
46 Zimmer Manufacturing B.V. II May-16-2016
47 Zimmer Manufacturing B.V. II Mar-12-2016
48 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
49 Zimmer, Inc. II Jul-30-2024
50 Zimmer, Inc. II Sep-07-2023
51 Zimmer, Inc. II Oct-20-2014
52 Zimmer, Inc. II Aug-26-2014
53 Zimmer, Inc. II Feb-20-2014
54 Zimmer, Inc. II Dec-30-2013
55 Zimmer, Inc. II Nov-14-2013
56 Zimmer, Inc. II Oct-25-2013
57 Zimmer, Inc. II Nov-06-2012
58 Zimmer, Inc. II Oct-15-2012
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