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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
Definition Replacement of the humeral head for total anatomic shoulder arthroplasty
Product CodePKC
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IGNITE ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 14 14
2022 31 31
2023 45 45
2024 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 84 84
Device Dislodged or Dislocated 23 23
Appropriate Term/Code Not Available 17 17
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Use of Device Problem 4 4
Osseointegration Problem 4 4
Patient Device Interaction Problem 3 3
No Apparent Adverse Event 3 3
Migration 3 3
Unstable 2 2
Material Split, Cut or Torn 2 2
Difficult to Remove 2 2
Inadequacy of Device Shape and/or Size 2 2
Fracture 2 2
Naturally Worn 2 2
Device-Device Incompatibility 1 1
Output Problem 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1
Degraded 1 1
Lack of Effect 1 1
Loose or Intermittent Connection 1 1
Mechanical Jam 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 24 24
Insufficient Information 24 24
Implant Pain 18 18
Pain 16 16
Joint Laxity 14 14
Unspecified Tissue Injury 14 14
Joint Dislocation 10 10
Failure of Implant 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Clinical Signs, Symptoms or Conditions 6 6
Loss of Range of Motion 6 6
Bacterial Infection 6 6
Arthralgia 5 5
Metal Related Pathology 5 5
Inadequate Osseointegration 5 5
Osteolysis 4 4
No Information 2 2
Unspecified Musculoskeletal problem 2 2
Bone Fracture(s) 2 2
Rupture 2 2
Cardiac Arrest 2 2
Fall 2 2
Limb Fracture 2 2
Swelling/ Edema 2 2
Dysphasia 1 1
Hypersensitivity/Allergic reaction 1 1
No Code Available 1 1
Muscular Rigidity 1 1
Subluxation 1 1
Muscle/Tendon Damage 1 1
Toxicity 1 1
Non-union Bone Fracture 1 1
Erosion 1 1

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