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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
Product CodeMEH
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
CONFORMIS INC
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 1
NEXTSTEP ARTHROPEDIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 336 336
2020 337 337
2021 372 372
2022 316 316
2023 335 335
2024 273 273

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 575 575
Device-Device Incompatibility 316 316
Insufficient Information 282 282
Device Dislodged or Dislocated 182 182
Appropriate Term/Code Not Available 153 153
Break 96 96
Osseointegration Problem 78 78
Fracture 64 64
Degraded 51 51
Detachment of Device or Device Component 49 49
Migration 42 42
Loosening of Implant Not Related to Bone-Ingrowth 40 40
Loose or Intermittent Connection 36 36
Material Erosion 35 35
Corroded 25 25
Device Appears to Trigger Rejection 24 24
Device Contaminated During Manufacture or Shipping 23 23
Unstable 22 22
Tear, Rip or Hole in Device Packaging 22 22
Naturally Worn 16 16
Loss of Osseointegration 14 14
Malposition of Device 14 14
Inadequacy of Device Shape and/or Size 8 8
Use of Device Problem 8 8
Failure to Cut 7 7
Noise, Audible 6 6
Inaccurate Information 6 6
Material Deformation 6 6
Mechanical Problem 6 6
Unintended Movement 6 6
Patient-Device Incompatibility 6 6
Migration or Expulsion of Device 5 5
Patient Device Interaction Problem 4 4
Material Integrity Problem 4 4
Difficult to Insert 4 4
Defective Device 4 4
Off-Label Use 4 4
Compatibility Problem 3 3
Difficult to Remove 3 3
Positioning Problem 3 3
Component Missing 3 3
Nonstandard Device 3 3
Device Damaged Prior to Use 3 3
No Apparent Adverse Event 3 3
Material Fragmentation 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Mechanical Jam 2 2
Failure to Osseointegrate 2 2
Delivered as Unsterile Product 2 2
Calibration Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 357 357
Pain 335 335
Injury 209 209
Metal Related Pathology 157 157
Insufficient Information 151 151
Joint Dislocation 146 146
Inflammation 138 138
No Clinical Signs, Symptoms or Conditions 134 134
Foreign Body Reaction 131 131
Limb Fracture 123 123
Inadequate Osseointegration 95 95
Reaction 90 90
Failure of Implant 78 78
Fall 73 73
Bone Fracture(s) 70 70
Ambulation Difficulties 65 65
No Consequences Or Impact To Patient 49 49
No Known Impact Or Consequence To Patient 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Osteolysis 36 36
Joint Laxity 34 34
No Code Available 24 24
No Patient Involvement 21 21
Implant Pain 16 16
Joint Disorder 16 16
Discomfort 16 16
Hip Fracture 15 15
Loss of Range of Motion 15 15
Local Reaction 14 14
Bacterial Infection 12 12
Physical Asymmetry 11 11
Swelling/ Edema 11 11
Muscle/Tendon Damage 11 11
No Information 11 11
Unequal Limb Length 10 10
Necrosis 10 10
Hematoma 9 9
Wound Dehiscence 7 7
Ossification 6 6
Unspecified Tissue Injury 6 6
Heart Failure/Congestive Heart Failure 5 5
Host-Tissue Reaction 5 5
Cyst(s) 5 5
Hemorrhage/Bleeding 5 5
Deformity/ Disfigurement 5 5
Tissue Damage 5 5
Erythema 4 4
Nerve Damage 4 4
Fluid Discharge 4 4
Foreign Body In Patient 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Corin Ltd II Sep-30-2021
3 Corin Ltd II Jun-11-2021
4 Corin Ltd II Mar-22-2021
5 Exactech, Inc. II Sep-09-2022
6 Signature Orthopaedics Europe Ltd II Mar-25-2020
7 Signature Orthopedics Pty Limited II May-28-2021
8 Waldemar Link GmbH & Co. KG (Mfg Site) II Jan-11-2019
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