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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
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP
  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
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 5 5
2019 8 8
2020 5 5
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 6 6
Appropriate Term/Code Not Available 4 4
Device Dislodged or Dislocated 4 4
Inadequacy of Device Shape and/or Size 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Physical Resistance/Sticking 1 1
Noise, Audible 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Failure To Adhere Or Bond 1 1
Migration or Expulsion of Device 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
No Information 6 6
Arthralgia 4 4
Unspecified Infection 3 3
Failure of Implant 3 3
Joint Dislocation 2 2
Bacterial Infection 2 2
No Code Available 2 2
Inadequate Osseointegration 1 1
Limited Mobility Of The Implanted Joint 1 1
No Known Impact Or Consequence To Patient 1 1
Metal Related Pathology 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Toxicity 1 1
Erosion 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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