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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
B-ONE ORTHO CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET UK LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 2
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 5
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 3
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 10
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORCHARD MEDICAL DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORCHARD MEDICAL DEVELOPMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SERF
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 6
WALDEMAR LINK GMBH & CO.KG
  SUBSTANTIALLY EQUIVALENT 1
XERXES ARTHOPEDIX LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
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 4314 4434
Device Dislodged or Dislocated 2468 2474
Insufficient Information 1232 1245
Appropriate Term/Code Not Available 1000 1000
Fracture 923 923
Osseointegration Problem 477 490
Naturally Worn 458 502
Break 340 340
Loosening of Implant Not Related to Bone-Ingrowth 289 313
Material Erosion 268 268
Loose or Intermittent Connection 245 245
Migration 228 371
Corroded 189 189
Unstable 173 173
Noise, Audible 154 154
Device Appears to Trigger Rejection 144 144
Loss of Osseointegration 136 136
Patient Device Interaction Problem 120 120
Difficult to Insert 97 97
Detachment of Device or Device Component 97 97
Manufacturing, Packaging or Shipping Problem 89 89
Tear, Rip or Hole in Device Packaging 87 87
Inadequacy of Device Shape and/or Size 74 74
Packaging Problem 71 71
Degraded 69 69
Malposition of Device 62 62
Failure to Osseointegrate 61 61
Use of Device Problem 53 53
No Apparent Adverse Event 53 53
Unintended Movement 51 51
Mechanical Problem 49 49
Biocompatibility 45 45
Device Contaminated During Manufacture or Shipping 43 43
Material Integrity Problem 40 40
Crack 40 40
Migration or Expulsion of Device 35 35
Difficult to Remove 34 34
Positioning Problem 34 34
Patient-Device Incompatibility 34 34
Scratched Material 29 29
Improper or Incorrect Procedure or Method 28 28
Positioning Failure 26 26
Delivered as Unsterile Product 24 24
Fitting Problem 23 23
Mechanical Jam 21 21
Loss of or Failure to Bond 21 21
Device-Device Incompatibility 21 21
Inaccurate Information 20 20
Material Fragmentation 18 18
Wrong Label 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Dislocation 2298 2317
Pain 2223 2291
Unspecified Infection 2065 2109
No Code Available 1458 1458
No Clinical Signs, Symptoms or Conditions 1049 1093
Insufficient Information 898 1017
Failure of Implant 860 888
Inadequate Osseointegration 674 687
Bone Fracture(s) 615 636
No Information 521 521
Joint Laxity 435 435
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 388 388
Injury 372 372
Metal Related Pathology 339 339
Fall 333 333
No Known Impact Or Consequence To Patient 274 274
Osteolysis 261 298
Reaction 244 244
Foreign Body Reaction 241 241
Ambulation Difficulties 221 221
Limb Fracture 200 200
Test Result 195 195
Loss of Range of Motion 173 173
Inflammation 159 159
Tissue Damage 156 156
Joint Disorder 154 154
Discomfort 149 149
No Consequences Or Impact To Patient 111 111
Hip Fracture 103 103
Implant Pain 103 103
Swelling/ Edema 100 100
Hematoma 100 100
Limited Mobility Of The Implanted Joint 91 91
Hypersensitivity/Allergic reaction 89 89
Physical Asymmetry 87 87
Necrosis 87 87
Local Reaction 86 86
Ossification 82 82
Unspecified Tissue Injury 78 78
Scar Tissue 72 72
Unequal Limb Length 71 71
Bacterial Infection 67 67
Muscle/Tendon Damage 65 65
Fluid Discharge 59 59
Synovitis 58 58
Host-Tissue Reaction 57 57
Adhesion(s) 52 52
Wound Dehiscence 48 48
Swelling 47 47
Osteopenia/ Osteoporosis 46 46

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-18-2023
2 Biomet, Inc. II May-28-2020
3 Corin Ltd II Dec-19-2022
4 Encore Medical, LP II Sep-19-2023
5 Exactech, Inc. II Sep-09-2022
6 Exactech, Inc. II Aug-12-2021
7 Exactech, Inc. II Jul-22-2021
8 Howmedica Osteonics Corp. II Mar-31-2022
9 IMPLANTCAST GMBH II Jul-09-2021
10 OMNIlife science Inc. II Jan-26-2021
11 OMNIlife science Inc. II Sep-05-2019
12 Smith & Nephew Inc II May-24-2024
13 Smith & Nephew Orthopaedics AG II Aug-19-2020
14 Waldemar Link GmbH & Co. KG (Mfg Site) II Feb-29-2024
15 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-04-2023
16 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-14-2019
17 Zimmer Biomet, Inc. II Nov-07-2019
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