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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
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 1
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 4
KYOCERA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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
  1.  K203175  POLARSTEM Cemented Femoral Stem
  2.  K211548  POLARSTEM Calcar Reamer Guide
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
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 3071 3071
2020 1958 1958
2021 2200 2200
2022 1987 1987
2023 2075 2100
2024 2585 2900

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4656 4776
Device Dislodged or Dislocated 2572 2578
Insufficient Information 1254 1267
Appropriate Term/Code Not Available 1003 1003
Fracture 986 987
Osseointegration Problem 505 518
Naturally Worn 482 552
Break 345 345
Loosening of Implant Not Related to Bone-Ingrowth 303 327
Material Erosion 279 279
Migration 252 395
Loose or Intermittent Connection 245 245
Unstable 199 199
Corroded 191 191
Device Appears to Trigger Rejection 185 185
Noise, Audible 161 161
Loss of Osseointegration 140 140
Patient Device Interaction Problem 120 120
Difficult to Insert 107 107
Detachment of Device or Device Component 107 107
Manufacturing, Packaging or Shipping Problem 104 104
Tear, Rip or Hole in Device Packaging 92 92
Packaging Problem 81 81
Inadequacy of Device Shape and/or Size 76 76
Degraded 76 76
Malposition of Device 69 69
Failure to Osseointegrate 64 64
Use of Device Problem 56 56
No Apparent Adverse Event 53 53
Unintended Movement 51 51
Biocompatibility 51 51
Mechanical Problem 48 48
Device Contaminated During Manufacture or Shipping 47 47
Material Integrity Problem 43 43
Crack 41 41
Patient-Device Incompatibility 41 41
Migration or Expulsion of Device 35 35
Positioning Problem 35 35
Difficult to Remove 35 35
Improper or Incorrect Procedure or Method 30 30
Scratched Material 30 30
Positioning Failure 29 29
Delivered as Unsterile Product 27 27
Fitting Problem 23 23
Off-Label Use 22 22
Inaccurate Information 22 22
Mechanical Jam 21 21
Loss of or Failure to Bond 21 21
Device-Device Incompatibility 21 21
Device Damaged Prior to Use 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Dislocation 2427 2446
Pain 2342 2410
Unspecified Infection 2228 2272
No Code Available 1458 1458
No Clinical Signs, Symptoms or Conditions 1144 1188
Insufficient Information 996 1115
Failure of Implant 942 997
Inadequate Osseointegration 702 715
Bone Fracture(s) 648 669
No Information 521 521
Joint Laxity 488 488
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 417 417
Injury 367 367
Metal Related Pathology 365 365
Fall 340 340
Osteolysis 292 340
No Known Impact Or Consequence To Patient 274 274
Foreign Body Reaction 246 246
Ambulation Difficulties 240 240
Reaction 239 239
Limb Fracture 210 210
Test Result 195 195
Loss of Range of Motion 187 187
Inflammation 158 158
Tissue Damage 156 156
Discomfort 155 155
Joint Disorder 154 154
Implant Pain 138 138
Swelling/ Edema 115 115
No Consequences Or Impact To Patient 111 111
Hematoma 107 107
Hip Fracture 106 106
Physical Asymmetry 95 95
Hypersensitivity/Allergic reaction 93 93
Limited Mobility Of The Implanted Joint 91 91
Necrosis 90 90
Ossification 86 86
Local Reaction 86 86
Unequal Limb Length 84 84
Unspecified Tissue Injury 81 81
Scar Tissue 78 78
Bacterial Infection 75 75
Fluid Discharge 67 67
Synovitis 67 67
Muscle/Tendon Damage 66 66
Host-Tissue Reaction 57 57
Adhesion(s) 52 52
Wound Dehiscence 51 51
Osteopenia/ Osteoporosis 48 48
Swelling 47 47

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 Dec-26-2024
15 Waldemar Link GmbH & Co. KG (Mfg Site) II Feb-29-2024
16 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-04-2023
17 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-14-2019
18 Zimmer Biomet, Inc. II Nov-07-2019
19 Zimmer GmbH II Sep-12-2024
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