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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 2
CORIN U.S.A. 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
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
NEXTSTEP ARTHROPEDIX
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 2
SIGNATURE ORTHOPAEDICS PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 338 340
2021 372 378
2022 316 321
2023 334 341
2024 352 355
2025 446 985

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 778 1327
Device-Device Incompatibility 353 355
Insufficient Information 197 199
Device Dislodged or Dislocated 183 187
Osseointegration Problem 121 660
Appropriate Term/Code Not Available 115 115
Fracture 64 583
Break 58 59
Migration 54 572
Detachment of Device or Device Component 54 55
Device Appears to Trigger Rejection 52 52
Device Markings/Labelling Problem 48 48
Loosening of Implant Not Related to Bone-Ingrowth 47 48
Degraded 40 44
Material Erosion 35 555
Naturally Worn 30 547
Device Contaminated During Manufacture or Shipping 27 27
Tear, Rip or Hole in Device Packaging 25 25
Corroded 22 22
Unstable 21 21
Loss of Osseointegration 17 18
Loose or Intermittent Connection 13 13
Malposition of Device 11 528
Use of Device Problem 10 10
Inadequacy of Device Shape and/or Size 7 7
Failure to Cut 7 7
Noise, Audible 6 6
Inaccurate Information 6 7
Positioning Problem 6 6
Material Integrity Problem 5 5
Patient-Device Incompatibility 5 5
Patient Device Interaction Problem 4 4
Mechanical Problem 4 4
Difficult to Insert 4 4
Off-Label Use 4 4
Failure to Osseointegrate 4 4
Nonstandard Device 4 5
Defective Device 4 4
Material Deformation 4 4
Difficult to Remove 3 3
Compatibility Problem 3 3
Component Missing 3 3
Device Damaged Prior to Use 3 3
No Apparent Adverse Event 3 3
Unintended Movement 3 3
Improper or Incorrect Procedure or Method 2 541
Migration or Expulsion of Device 2 2
Incomplete or Missing Packaging 2 2
Difficult to Open or Remove Packaging Material 2 2
Crack 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 424 967
Pain 373 920
Insufficient Information 216 758
No Clinical Signs, Symptoms or Conditions 209 210
Limb Fracture 172 172
Metal Related Pathology 172 698
Joint Dislocation 167 707
Foreign Body Reaction 148 154
Inadequate Osseointegration 137 138
Inflammation 105 105
Fall 96 98
Ambulation Difficulties 90 94
Failure of Implant 71 72
Bone Fracture(s) 70 74
Injury 58 58
Joint Laxity 48 565
Reaction 48 48
Osteolysis 43 583
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 44
Implant Pain 29 29
Discomfort 22 26
No Known Impact Or Consequence To Patient 18 18
No Patient Involvement 17 17
Swelling/ Edema 15 18
Unequal Limb Length 15 554
Loss of Range of Motion 15 17
Bacterial Infection 14 14
Hip Fracture 14 14
Muscle/Tendon Damage 14 16
Local Reaction 14 36
Physical Asymmetry 13 14
No Code Available 13 13
Necrosis 11 530
Hematoma 9 10
Fluid Discharge 8 8
Deformity/ Disfigurement 7 548
Wound Dehiscence 7 8
No Information 7 7
Unspecified Tissue Injury 6 9
Ossification 6 524
Cyst(s) 6 8
Arthralgia 5 522
Hypersensitivity/Allergic reaction 5 8
Tissue Damage 5 5
Joint Disorder 5 5
Heart Failure/Congestive Heart Failure 5 5
No Consequences Or Impact To Patient 5 5
Host-Tissue Reaction 4 4
Sepsis 4 4
Impaired Healing 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 Theken Companies LLC II Oct-21-2025
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