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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device shoulder prosthesis, reverse configuration
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Definition Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Product CodePHX
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 6
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 5
FOURNITURES HOSPITALIERES
  SUBSTANTIALLY EQUIVALENT 3
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 3
FX SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
INTEGRA
  SUBSTANTIALLY EQUIVALENT 4
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 5
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 2
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Adverse Event Without Identified Device or Use Problem 54
Device Dislodged or Dislocated 36
Fracture 20
Detachment of Device or device Component 18
Positioning Problem 12
Material Integrity Problem 10
Insufficient Information 9
Naturally Worn 7
Separation Failure 7
Migration or Expulsion of Device 6
Break 6
Device Slipped 5
Material Fragmentation 4
Difficult to Insert 4
Unintended Movement 4
Device Operates Differently Than Expected 4
Loss of or Failure to Bond 4
Inadequacy of Device Shape and/or Size 3
Mechanical Problem 3
Loosening of Implant Not Related to Bone-Ingrowth 3
Material Deformation 3
Device Appears to Trigger Rejection 3
Difficult to Advance 3
Unstable 3
Positioning Failure 3
Malposition of device 3
Migration 3
Difficult or Delayed Separation 2
Component Missing 2
Mechanical Jam 2
Fitting Problem 1
Loss of Osseointegration 1
Material Twisted / Bent 1
Failure to Advance 1
Patient Device Interaction Problem 1
Appropriate Term/Code Not Available 1
Difficult to Remove 1
Activation, Positioning or Separation Problem 1
Device Operational Issue 1
Patient-Device Incompatibility 1
Total Device Problems 256

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-28-2020
2 Biomet, Inc. II Apr-20-2020
3 Biomet, Inc. II Mar-31-2020
4 Encore Medical, Lp II Mar-05-2018
5 Encore Medical, Lp II Jan-09-2016
6 Encore Medical, Lp II Oct-16-2015
7 Exactech, Inc. II Jan-28-2020
8 Exactech, Inc. II Feb-26-2019
9 Tornier, Inc II Nov-14-2019

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