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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
CORIN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  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 5
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
2021 372 378
2022 316 321
2023 334 341
2024 354 357
2025 474 1013
2026 207 215

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 831 1387
Device-Device Incompatibility 301 303
Osseointegration Problem 138 685
Insufficient Device Problem Information 134 135
Device Dislodged or Dislocated 118 119
Device Appears to Trigger Rejection 66 66
Fracture 58 584
Migration 57 575
Device Markings/Labelling Problem 48 48
Detachment of Device or Device Component 44 45
Naturally Worn 43 560
Loosening of Implant Not Related to Bone-Ingrowth 42 42
Break 38 38
Degraded 33 37
Tear, Rip or Hole in Device Packaging 32 32
Material Erosion 29 557
Device Contaminated During Manufacture or Shipping 23 23
Corroded 20 20
Unstable 18 18
Loss of Osseointegration 18 19
Appropriate Device Problem Term/Code Not Available 14 14
Use of Device Problem 10 10
Malposition of Device 10 535
Failure to Cut 7 7
Noise, Audible 6 6
Inaccurate Information 6 7
No Apparent Adverse Event 6 6
Material Integrity Problem 5 5
Positioning Problem 5 5
Off-Label Use 5 5
Difficult to Insert 5 5
Mechanical Problem 4 4
Improper or Incorrect Procedure or Method 4 551
Patient Device Interaction Problem 4 4
Implant subsidence 4 4
Failure to Osseointegrate 4 4
Material Deformation 4 4
Defective Device 3 3
Difficult to Remove 3 3
Difficult to Open or Remove Packaging Material 3 3
Device Damaged Prior to Use 3 3
Loss of or Failure to Bond 2 2
Incomplete or Missing Packaging 2 2
Nonstandard Device 2 2
Crack 2 2
Peeled/Delaminated 2 2
Delivered as Unsterile Product 2 2
Separation Failure 2 2
Difficult to Advance 2 2
Material Fragmentation 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 407 957
Pain 368 921
Insufficient Information 230 780
No Clinical Signs, Symptoms or Conditions 222 223
Limb Fracture 213 213
Metal Related Pathology 182 716
Inadequate Osseointegration 147 148
Joint Dislocation 145 693
Foreign Body Reaction 138 144
Fall 111 113
Ambulation or Postural Difficulties 70 73
Joint Laxity 68 593
Medical device site infection 61 578
Osteolysis 53 601
Bone Fracture(s) 53 56
Failure of Implant 52 53
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 43 46
Implant Pain 32 32
Discomfort 22 25
Inflammation 21 21
Unequal Limb Length 18 565
Loss of Range of Motion 18 20
Aseptic loosening 16 563
Swelling/ Edema 16 19
Muscle/Tendon Damage 15 17
Physical Asymmetry 14 15
Hip Fracture 13 13
Bacterial Infection 12 12
Necrosis 11 530
Wound Dehiscence 9 10
Periprosthetic fracture 9 556
High metal ion levels 8 8
Deformity/ Disfigurement 8 557
Fluid Discharge 8 8
Cyst(s) 7 9
Hematoma 7 8
Extraskeletal ossification 7 533
Joint Impingement 7 8
Unspecified Tissue Injury 7 10
Hypersensitivity/Allergic reaction 6 9
Hemorrhage/Blood Loss/Bleeding 6 6
Local Reaction 6 28
Synovitis 6 523
Heart Failure/Congestive Heart Failure 5 5
Arthralgia 5 522
Impaired Healing 4 4
Cellulitis 4 4
Foreign Body In Patient 4 4
Nerve Damage 4 4
Numbness 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Corin Ltd II Sep-30-2021
2 Corin Ltd II Jun-11-2021
3 Corin Ltd II Mar-22-2021
4 Exactech, Inc. II Sep-09-2022
5 Signature Orthopedics Pty Limited II May-28-2021
6 Theken Companies LLC II Oct-21-2025
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