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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, shoulder, semi-constrained, metal/polymer, uncemented
Regulation Description Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
Product CodeMBF
Regulation Number 888.3670
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
FOURNITURES HOSPITALIERES
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 165
Unstable 92
Adverse Event Without Identified Device or Use Problem 73
Migration or Expulsion of Device 29
Device Dislodged or Dislocated 26
Appropriate Term/Code Not Available 16
Noise, Audible 14
Detachment of Device or device Component 14
Packaging Problem 13
Inadequacy of Device Shape and/or Size 8
Detachment Of Device Component 7
Malposition of device 7
Migration 4
Fracture 4
Difficult to Remove 4
Naturally Worn 4
Mechanical Problem 4
Unintended Movement 3
Difficult to Insert 3
Manufacturing, Packaging or Shipping Problem 3
Improper or Incorrect Procedure or Method 3
Component Missing 2
Device Packaging Compromised 2
Device Markings / Labelling Problem 2
Device-Device Incompatibility 2
Material Erosion 2
Positioning Problem 2
Loss of Osseointegration 2
Defective Device 2
Device Damaged by Another Device 1
Mechanical Jam 1
Material Separation 1
Failure To Adhere Or Bond 1
Incorrect Measurement 1
Disassembly 1
Material Disintegration 1
Loosening of Implant Not Related to Bone-Ingrowth 1
Material Twisted / Bent 1
Disconnection 1
Off-Label Use 1
Scratched Material 1
Separation Failure 1
Difficult To Position 1
Corroded 1
Positioning Failure 1
Shipping Damage or Problem 1
Device Slipped 1
Total Device Problems 530

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. III Jun-11-2015
2 Zimmer Biomet, Inc. II Nov-22-2019
3 Zimmer Biomet, Inc. II Dec-07-2018
4 Zimmer Biomet, Inc. II Dec-29-2017

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