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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, uncemented, metal / polymer, non-porous, calcium phosphate
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
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
EXACTECH, INC.
  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 2
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 337 337
2021 372 372
2022 316 316
2023 334 334
2024 355 355
2025 116 116

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 654 654
Device-Device Incompatibility 325 325
Insufficient Information 192 192
Device Dislodged or Dislocated 162 162
Appropriate Term/Code Not Available 116 116
Osseointegration Problem 90 90
Fracture 58 58
Break 55 55
Detachment of Device or Device Component 49 49
Migration 39 39
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Degraded 35 35
Device Appears to Trigger Rejection 34 34
Material Erosion 32 32
Device Contaminated During Manufacture or Shipping 23 23
Tear, Rip or Hole in Device Packaging 21 21
Corroded 20 20
Naturally Worn 18 18
Unstable 17 17
Loss of Osseointegration 14 14
Loose or Intermittent Connection 13 13
Malposition of Device 10 10
Use of Device Problem 9 9
Inadequacy of Device Shape and/or Size 7 7
Failure to Cut 7 7
Noise, Audible 6 6
Inaccurate Information 6 6
Patient-Device Incompatibility 5 5
Patient Device Interaction Problem 4 4
Mechanical Problem 4 4
Off-Label Use 4 4
Difficult to Insert 4 4
Defective Device 4 4
Compatibility Problem 3 3
Component Missing 3 3
Device Damaged Prior to Use 3 3
Failure to Osseointegrate 3 3
Material Integrity Problem 3 3
Unintended Movement 3 3
Material Deformation 3 3
No Apparent Adverse Event 3 3
Migration or Expulsion of Device 2 2
Incomplete or Missing Packaging 2 2
Difficult to Open or Remove Packaging Material 2 2
Nonstandard Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Delivered as Unsterile Product 2 2
Positioning Problem 2 2
Material Fragmentation 2 2
Difficult to Remove 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 364 364
Pain 321 321
Insufficient Information 181 181
Metal Related Pathology 152 152
Joint Dislocation 150 150
No Clinical Signs, Symptoms or Conditions 144 144
Limb Fracture 136 136
Foreign Body Reaction 135 135
Inadequate Osseointegration 103 103
Inflammation 102 102
Ambulation Difficulties 88 88
Fall 76 76
Failure of Implant 70 70
Bone Fracture(s) 66 66
Injury 58 58
Reaction 48 48
Joint Laxity 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Osteolysis 36 36
Implant Pain 19 19
No Known Impact Or Consequence To Patient 18 18
No Patient Involvement 17 17
Discomfort 16 16
Bacterial Infection 14 14
Loss of Range of Motion 14 14
Swelling/ Edema 13 13
No Code Available 13 13
Hip Fracture 13 13
Muscle/Tendon Damage 13 13
Local Reaction 13 13
Physical Asymmetry 11 11
Unequal Limb Length 11 11
Necrosis 10 10
Hematoma 8 8
No Information 7 7
Wound Dehiscence 7 7
Unspecified Tissue Injury 6 6
Joint Disorder 5 5
Tissue Damage 5 5
Cyst(s) 5 5
Heart Failure/Congestive Heart Failure 5 5
Ossification 5 5
No Consequences Or Impact To Patient 5 5
Deformity/ Disfigurement 5 5
Host-Tissue Reaction 4 4
Fluid Discharge 4 4
Hemorrhage/Bleeding 4 4
Nerve Damage 4 4
Erythema 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
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