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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, shoulder, hemi-, humeral, metallic uncemented
Regulation Description Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Product CodeHSD
Regulation Number 888.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Insufficient Information 868
Adverse Event Without Identified Device or Use Problem 646
Device Dislodged or Dislocated 596
Loss of Osseointegration 172
Break 155
Fracture 150
Appropriate Term/Code Not Available 124
Migration or Expulsion of Device 79
Naturally Worn 74
Disassembly 60
Loss of or Failure to Bond 59
Unstable 57
Difficult to Insert 40
Detachment of Device or device Component 39
Malposition of device 38
Osseointegration Problem 33
Loose or Intermittent Connection 32
Loosening of Implant Not Related to Bone-Ingrowth 32
Fitting Problem 30
Failure To Adhere Or Bond 27
Detachment Of Device Component 20
Migration 18
Inadequacy of Device Shape and/or Size 17
Device-Device Incompatibility 16
Material Erosion 15
Mechanical Jam 14
Material Deformation 12
Noise, Audible 12
Difficult to Remove 12
Use of Device Problem 11
Metal Shedding Debris 9
Material Separation 9
Device Operates Differently Than Expected 9
Positioning Problem 9
Component Missing 9
Connection Problem 9
Misconnection 8
Failure to Osseointegrate 8
Mechanical Problem 7
Packaging Problem 7
Device Slipped 6
Defective Component 6
Separation Problem 5
Unintended System Motion 5
Bent 5
Failure to Advance 5
Off-Label Use 4
Material Fragmentation 3
Patient Device Interaction Problem 3
Misassembled 3
Dull, Blunt 3
Defective Device 2
Crack 2
Tear, Rip or Hole in Device Packaging 2
Device Abrasion From Instrument Or Another Object 2
Compatibility Problem 2
Unintended Movement 2
Scratched Material 2
Difficult or Delayed Positioning 2
Positioning Failure 2
Contamination / decontamination Problem 2
Separation Failure 2
Plate 1
Entrapment of Device 1
Nonstandard device 1
Difficult To Position 1
Incorrect Device Or Component Shipped 1
Device Misassembled During Manufacturing / Shipping 1
Device Operational Issue 1
Particulates 1
Incomplete or Missing Packaging 1
Disconnection 1
Patient-Device Incompatibility 1
Delamination 1
Thread 1
Manufacturing, Packaging or Shipping Problem 1
Physical Resistance / Sticking 1
Material Twisted / Bent 1
Incorrect Measurement 1
Material Disintegration 1
Component Incompatible 1
Decoupling 1
Tip 1
Peeled / Delaminated 1
Pitted 1
Split 1
Difficult to Advance 1
Delivered as Unsterile Product 1
Failure to Disconnect 1
Deformation Due to Compressive Stress 1
Torn Material 1
Screw 1
Electronic Property Issue 1
Total Device Problems 3643

Recalls
Manufacturer Recall Class Date Posted
1 Arthrosurface, Inc. II Feb-12-2015
2 Ascension Orthopedics, Inc III Feb-02-2019
3 DePuy Orthopaedics, Inc. II Mar-01-2018
4 Fx Solutions II Jul-17-2018
5 Limacorporate S.p.A II Sep-02-2015
6 Zimmer Biomet, Inc. II Mar-13-2018

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