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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
BIOMET MANUFACTURING CORP
  SUBSTANTIALLY EQUIVALENT 1
DEPUY (IRELAND)
  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

MDR Year MDR Reports MDR Events
2019 8 8
2020 5 5
2021 14 14
2022 31 31
2023 45 45
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 71 71
Device Dislodged or Dislocated 21 21
Appropriate Term/Code Not Available 17 17
Insufficient Information 5 5
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Patient Device Interaction Problem 3 3
Difficult to Remove 3 3
Migration 3 3
No Apparent Adverse Event 3 3
Naturally Worn 3 3
Use of Device Problem 3 3
Material Split, Cut or Torn 2 2
Osseointegration Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Fracture 2 2
Device-Device Incompatibility 1 1
Unstable 1 1
Material Integrity Problem 1 1
Degraded 1 1
Mechanical Jam 1 1
Loose or Intermittent Connection 1 1
Physical Resistance/Sticking 1 1
Migration or Expulsion of Device 1 1
Output Problem 1 1
Noise, Audible 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 24 24
Unspecified Infection 20 20
Pain 16 16
Joint Laxity 13 13
Implant Pain 12 12
Unspecified Tissue Injury 12 12
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
Arthralgia 5 5
Metal Related Pathology 5 5
No Information 5 5
Loss of Range of Motion 4 4
Osteolysis 3 3
Bacterial Infection 3 3
Unspecified Musculoskeletal problem 2 2
Cardiac Arrest 2 2
Fall 2 2
Limb Fracture 2 2
Swelling/ Edema 2 2
Hypersensitivity/Allergic reaction 1 1
Inadequate Osseointegration 1 1
Limited Mobility Of The Implanted Joint 1 1
No Code Available 1 1
Bone Fracture(s) 1 1
No Known Impact Or Consequence To Patient 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
2 Zimmer Biomet, Inc. II Nov-07-2019
3 Zimmer GmbH II Sep-27-2019
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