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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
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 245 245

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 565 565
Device-Device Incompatibility 313 313
Insufficient Information 282 282
Device Dislodged or Dislocated 182 182
Appropriate Term/Code Not Available 153 153
Break 96 96
Osseointegration Problem 76 76
Fracture 61 61
Degraded 49 49
Detachment of Device or Device Component 49 49
Loosening of Implant Not Related to Bone-Ingrowth 39 39
Migration 39 39
Loose or Intermittent Connection 36 36
Material Erosion 35 35
Corroded 25 25
Device Appears to Trigger Rejection 23 23
Unstable 22 22
Device Contaminated During Manufacture or Shipping 22 22
Tear, Rip or Hole in Device Packaging 21 21
Loss of Osseointegration 14 14
Malposition of Device 14 14
Naturally Worn 14 14
Inadequacy of Device Shape and/or Size 8 8
Use of Device Problem 8 8
Failure to Cut 7 7
Patient-Device Incompatibility 6 6
Material Deformation 6 6
Noise, Audible 6 6
Unintended Movement 6 6
Mechanical Problem 6 6
Inaccurate Information 6 6
Migration or Expulsion of Device 5 5
Difficult to Insert 4 4
Off-Label Use 4 4
Patient Device Interaction Problem 4 4
Defective Device 4 4
Component Missing 3 3
No Apparent Adverse Event 3 3
Positioning Problem 3 3
Material Integrity Problem 3 3
Compatibility Problem 3 3
Device Damaged Prior to Use 3 3
Difficult to Remove 3 3
Nonstandard Device 3 3
Delivered as Unsterile Product 2 2
Failure to Osseointegrate 2 2
Material Fragmentation 2 2
Mechanical Jam 2 2
Incomplete or Missing Packaging 2 2
Calibration Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 352 352
Pain 331 331
Injury 209 209
Metal Related Pathology 156 156
Joint Dislocation 146 146
Insufficient Information 145 145
Inflammation 138 138
No Clinical Signs, Symptoms or Conditions 132 132
Foreign Body Reaction 131 131
Limb Fracture 119 119
Inadequate Osseointegration 94 94
Reaction 90 90
Failure of Implant 76 76
Fall 72 72
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 34 34
Joint Laxity 34 34
No Code Available 24 24
No Patient Involvement 21 21
Joint Disorder 16 16
Implant Pain 16 16
Hip Fracture 14 14
Local Reaction 14 14
Loss of Range of Motion 13 13
Discomfort 13 13
Bacterial Infection 12 12
Muscle/Tendon Damage 11 11
Physical Asymmetry 11 11
No Information 11 11
Swelling/ Edema 10 10
Necrosis 10 10
Unequal Limb Length 10 10
Hematoma 9 9
Wound Dehiscence 7 7
Unspecified Tissue Injury 6 6
Ossification 6 6
Host-Tissue Reaction 5 5
Tissue Damage 5 5
Heart Failure/Congestive Heart Failure 5 5
Hemorrhage/Bleeding 5 5
Deformity/ Disfigurement 5 5
Cyst(s) 4 4
Fluid Discharge 4 4
Foreign Body In Patient 4 4
Nerve Damage 4 4
Synovitis 3 3

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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