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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Definition Replacement of the humeral head for total anatomic shoulder arthroplasty
Product CodePKC
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY(IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IGNITE ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMA CORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 14 14
2022 31 31
2023 46 47
2024 54 55
2025 89 89
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 153 154
Device Dislodged or Dislocated 26 26
Appropriate Term/Code Not Available 16 16
Unstable 9 9
Osseointegration Problem 7 7
Use of Device Problem 6 6
Insufficient Information 5 5
No Apparent Adverse Event 5 5
Migration 5 5
Patient Device Interaction Problem 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Naturally Worn 3 3
Loss of or Failure to Bond 3 3
Material Split, Cut or Torn 2 2
Break 2 2
Unintended Movement 2 2
Difficult to Remove 2 2
Lack of Effect 2 2
Inadequacy of Device Shape and/or Size 2 2
Fracture 2 2
Device-Device Incompatibility 1 1
Output Problem 1 1
Material Integrity Problem 1 2
Degraded 1 1
Difficult to Insert 1 1
Misassembly by Users 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 35 35
Pain 35 36
Unspecified Infection 32 32
Implant Pain 29 29
Unspecified Tissue Injury 27 27
Joint Laxity 20 20
Joint Dislocation 13 13
Muscle/Tendon Damage 13 13
No Clinical Signs, Symptoms or Conditions 9 9
Bone Fracture(s) 9 10
Loss of Range of Motion 9 9
Failure of Implant 8 8
Inadequate Osseointegration 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Bacterial Infection 6 6
Metal Related Pathology 5 5
Fall 5 5
Osteolysis 4 4
Arthralgia 3 3
Unspecified Musculoskeletal problem 2 2
Necrosis 2 2
Rupture 2 2
Cardiac Arrest 2 2
Bone Shedding Debris 2 2
Muscular Rigidity 2 2
Subluxation 2 2
Limb Fracture 2 2
Swelling/ Edema 2 2
Erosion 2 2
Dysphasia 1 1
Hypersensitivity/Allergic reaction 1 1
Fatigue 1 1
No Information 1 1
Hematoma 1 1
Ossification 1 1
Discomfort 1 1
Non-union Bone Fracture 1 1
Arthritis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Tornier, Inc II Sep-16-2024
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