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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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 51 51
Device Dislodged or Dislocated 20 20
Appropriate Term/Code Not Available 17 17
Insufficient Information 5 5
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Migration 3 3
Patient Device Interaction Problem 3 3
No Apparent Adverse Event 3 3
Naturally Worn 3 3
Difficult to Remove 3 3
Inadequacy of Device Shape and/or Size 2 2
Fracture 2 2
Osseointegration Problem 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 1 1
Output Problem 1 1
Degraded 1 1
Noise, Audible 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Unstable 1 1
Use of Device Problem 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 22 22
Pain 15 15
Unspecified Infection 14 14
Implant Pain 11 11
Joint Dislocation 9 9
Unspecified Tissue Injury 8 8
Joint Laxity 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Failure of Implant 7 7
Arthralgia 5 5
No Information 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Metal Related Pathology 5 5
Loss of Range of Motion 4 4
Osteolysis 3 3
Bacterial Infection 2 2
Cardiac Arrest 2 2
Fall 2 2
Limb Fracture 2 2
Unspecified Musculoskeletal problem 2 2
Swelling/ Edema 2 2
Subluxation 1 1
Muscle/Tendon Damage 1 1
Erosion 1 1
Toxicity 1 1
Muscular Rigidity 1 1
Inadequate Osseointegration 1 1
Limited Mobility Of The Implanted Joint 1 1
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. II Nov-07-2019
2 Zimmer GmbH II Sep-27-2019
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