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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/ceramic/polymer, cemented or non-porous, uncemented
Product CodeLZO
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP IMPLANTS SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
B-ONE ORTHO CORP.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET UK LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORIN U.S.A.
  SUBSTANTIALLY EQUIVALENT 5
CORIN USA
  SUBSTANTIALLY EQUIVALENT 14
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 6
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY FRANCE S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 5
DEPUY ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 9
GLOBAL MANUFACTURING TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ICONACY ORTHOPEDIC IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 4
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 3
KYOCERA MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 8
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 10
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 17
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 4
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 8
MICROPORT ORTHOPEDICS INC. (MPO)
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
OMNI LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 3
OMNILIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 2
ORCHARD MEDICAL DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORCHARD MEDICAL DEVELOPMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
OTIS BIOTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SERF
  SUBSTANTIALLY EQUIVALENT 4
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 14
TGM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
UNITED ORTHOPEDIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 8
WALDEMAR LINK GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 7
XERXES ARTHOPEDIX LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 10
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2014 1467 1467
2015 1343 1343
2016 1727 1727
2017 2159 2159
2018 3128 3128
2019 3076 3076
2020 1957 1957
2021 2200 2200
2022 1985 1985
2023 2074 2099
2024 1794 2082

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5214 5334
Insufficient Information 4784 4797
Device Dislodged or Dislocated 4478 4484
Appropriate Term/Code Not Available 1682 1682
Fracture 1477 1477
Naturally Worn 666 710
Break 627 627
Loose or Intermittent Connection 572 572
Osseointegration Problem 494 507
Material Erosion 361 361
Corroded 359 359
Unstable 356 356
Noise, Audible 311 311
Loosening of Implant Not Related to Bone-Ingrowth 298 322
Migration 241 384
Loss of Osseointegration 231 231
Migration or Expulsion of Device 219 219
Device Slipped 191 191
Metal Shedding Debris 171 171
Difficult to Insert 164 164
Malposition of Device 162 162
Inadequacy of Device Shape and/or Size 153 153
Device Appears to Trigger Rejection 145 145
Patient Device Interaction Problem 122 122
Tear, Rip or Hole in Device Packaging 119 119
Detachment of Device or Device Component 112 112
Device Operates Differently Than Expected 112 112
Packaging Problem 107 107
Patient-Device Incompatibility 99 99
Degraded 93 93
Manufacturing, Packaging or Shipping Problem 92 92
Material Integrity Problem 85 85
Mechanical Problem 84 84
Positioning Problem 81 81
Failure To Adhere Or Bond 75 75
Failure to Osseointegrate 74 74
No Apparent Adverse Event 69 69
Fitting Problem 67 67
Unintended Movement 66 66
Crack 64 64
Difficult to Remove 63 63
Use of Device Problem 58 58
Material Deformation 56 56
Improper or Incorrect Procedure or Method 54 54
Device Contaminated During Manufacture or Shipping 54 54
Nonstandard Device 51 51
Scratched Material 49 49
Biocompatibility 47 47
Device-Device Incompatibility 47 47
Loss of or Failure to Bond 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 4717 4785
Unspecified Infection 3606 3650
Joint Dislocation 3361 3380
No Code Available 2930 2930
No Information 2095 2095
Injury 1230 1230
No Clinical Signs, Symptoms or Conditions 1053 1097
Bone Fracture(s) 1028 1049
Failure of Implant 990 1018
Insufficient Information 899 1018
Reaction 742 742
Inadequate Osseointegration 733 746
No Known Impact Or Consequence To Patient 595 595
Fall 501 501
Inflammation 493 493
Osteolysis 459 496
Joint Laxity 438 438
Ambulation Difficulties 433 433
Joint Disorder 413 413
Discomfort 406 406
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 394 394
Foreign Body Reaction 389 389
Tissue Damage 385 385
Metal Related Pathology 367 367
Loss of Range of Motion 329 329
Test Result 319 319
No Consequences Or Impact To Patient 291 291
Not Applicable 288 288
Limited Mobility Of The Implanted Joint 234 234
Toxicity 216 216
Host-Tissue Reaction 205 205
Hip Fracture 200 200
Limb Fracture 200 200
Swelling 194 194
Hematoma 181 181
Necrosis 168 168
Hypersensitivity/Allergic reaction 120 120
Local Reaction 118 118
Ossification 117 117
Bacterial Infection 105 105
Swelling/ Edema 104 104
Implant Pain 103 103
Scar Tissue 101 101
Impaired Healing 93 93
Synovitis 93 93
Blood Loss 92 92
Physical Asymmetry 89 89
Fluid Discharge 88 88
Unspecified Tissue Injury 81 81
Wound Dehiscence 74 74

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Inc II Aug-12-2011
2 Biomet, Inc. II Dec-18-2023
3 Biomet, Inc. II May-28-2020
4 Biomet, Inc. II Jan-13-2016
5 Biomet, Inc. II Apr-23-2012
6 Biomet, Inc. II Mar-02-2012
7 Biomet, Inc. II Jul-14-2009
8 Corin Ltd II Dec-19-2022
9 Corin USA Limited II Apr-22-2016
10 DePuy Orthopaedics, Inc. II Dec-17-2014
11 Encore Medical, LP II Sep-19-2023
12 Exactech, Inc. II Sep-09-2022
13 Exactech, Inc. II Aug-12-2021
14 Exactech, Inc. II Jul-22-2021
15 Exactech, Inc. II Jan-17-2017
16 Exactech, Inc. II Jul-05-2016
17 Exactech, Inc. II Jul-21-2014
18 Exactech, Inc. II Feb-05-2013
19 Howmedica Osteonics Corp. II Mar-31-2022
20 IMPLANTCAST GMBH II Jul-09-2021
21 IMPLANTCAST GMBH II Jul-20-2018
22 Medacta Usa Inc II Oct-19-2018
23 MicroPort Orthopedics Inc. II Jan-03-2017
24 MicroPort Orthopedics Inc. III Dec-01-2016
25 OMNIlife science Inc. II Jan-26-2021
26 OMNIlife science Inc. II Sep-05-2019
27 Omnilife Science Inc. II Jul-14-2015
28 Omnilife Science Inc. II Aug-15-2014
29 Ortho Development Corporation II Jan-13-2012
30 Ortho Development Corporation II Mar-16-2011
31 Orthopedic Alliance LLC II May-24-2013
32 Smith & Nephew Inc II May-24-2024
33 Smith & Nephew Orthopaedics AG II Aug-19-2020
34 Smith & Nephew, Inc. II Aug-29-2017
35 Stryker Howmedica Osteonics Corp. II Sep-28-2012
36 Stryker Howmedica Osteonics Corp. II Nov-16-2011
37 Stryker Howmedica Osteonics Corp. II Mar-11-2010
38 Stryker Howmedica Osteonics Corp. II Jan-11-2010
39 Stryker Howmedica Osteonics Corp. III Sep-14-2009
40 Stryker Howmedica Osteonics Corp. II May-21-2009
41 Stryker Howmedica Osteonics Corp. II Jan-26-2009
42 Stryker Howmedica Osteonics Corp. II Jan-26-2009
43 Waldemar Link GmbH & Co. KG (Mfg Site) II Feb-29-2024
44 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-04-2023
45 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-14-2019
46 Zimmer Biomet, Inc. II Nov-07-2019
47 Zimmer Biomet, Inc. II Apr-16-2018
48 Zimmer Biomet, Inc. II Mar-14-2018
49 Zimmer Biomet, Inc. II Dec-29-2017
50 Zimmer Biomet, Inc. II Mar-20-2017
51 Zimmer GmbH II Sep-12-2024
52 Zimmer GmbH II Dec-20-2018
53 Zimmer GmbH II Apr-26-2018
54 Zimmer Gmbh II Jul-26-2016
55 Zimmer Gmbh II Feb-20-2015
56 Zimmer Inc. II Jul-27-2009
57 Zimmer, Inc. II Feb-27-2015
58 Zimmer, Inc. II Nov-06-2012
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