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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
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 2
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 5 5
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 22 22
Appropriate Term/Code Not Available 20 20
Insufficient Information 6 6
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Difficult to Remove 3 3
Patient Device Interaction Problem 3 3
Use of Device Problem 3 3
No Apparent Adverse Event 3 3
Migration 3 3
Naturally Worn 3 3
Material Split, Cut or Torn 2 2
Inadequacy of Device Shape and/or Size 2 2
Fracture 2 2
Osseointegration Problem 2 2
Device-Device Incompatibility 1 1
Unstable 1 1
Material Integrity Problem 1 1
Degraded 1 1
Failure To Adhere Or Bond 1 1
Material Twisted/Bent 1 1
Migration or Expulsion of Device 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Noise, Audible 1 1
Mechanical Jam 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 24 24
Unspecified Infection 20 20
Pain 19 19
Joint Laxity 13 13
Implant Pain 12 12
Unspecified Tissue Injury 12 12
Joint Dislocation 10 10
Failure of Implant 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Clinical Signs, Symptoms or Conditions 6 6
No Information 6 6
Arthralgia 5 5
Metal Related Pathology 5 5
Loss of Range of Motion 4 4
Osteolysis 3 3
Bacterial Infection 3 3
No Code Available 2 2
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
Limited Mobility Of The Implanted Joint 1 1
Inadequate Osseointegration 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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