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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, shoulder, non-constrained, metal/polymer cemented
Product CodeKWT
Regulation Number 888.3650
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE LLC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
FX SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 2
LIMA-LTO S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS INC
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 168 168
2015 176 176
2016 445 445
2017 558 558
2018 481 481
2019 421 421
2020 216 216
2021 228 228
2022 275 275
2023 384 384
2024 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 997 997
Device Dislodged or Dislocated 615 615
Insufficient Information 387 387
Fracture 302 302
Loosening of Implant Not Related to Bone-Ingrowth 218 218
Loose or Intermittent Connection 213 213
Break 171 171
Appropriate Term/Code Not Available 160 160
Unstable 111 111
Detachment of Device or Device Component 103 103
Naturally Worn 100 100
Migration or Expulsion of Device 77 77
Device Slipped 74 74
Device Operates Differently Than Expected 50 50
Migration 44 44
Detachment Of Device Component 42 42
Loss of or Failure to Bond 31 31
Failure To Adhere Or Bond 28 28
Improper or Incorrect Procedure or Method 28 28
Mechanical Jam 26 26
Material Separation 22 22
Patient Device Interaction Problem 22 22
Difficult to Insert 20 20
Malposition of Device 19 19
Patient-Device Incompatibility 18 18
Difficult to Remove 16 16
Inadequacy of Device Shape and/or Size 16 16
Positioning Problem 15 15
Material Erosion 14 14
Loss of Osseointegration 14 14
Physical Resistance/Sticking 14 14
Unintended Movement 13 13
Mechanical Problem 13 13
Microbial Contamination of Device 12 12
Disassembly 12 12
Contamination 11 11
Torn Material 9 9
Noise, Audible 8 8
Material Deformation 8 8
Component Missing 8 8
Material Fragmentation 7 7
Entrapment of Device 7 7
Dull, Blunt 7 7
Material Split, Cut or Torn 6 6
Use of Device Problem 5 5
Component Falling 5 5
Defective Device 5 5
Misassembly by Users 5 5
Separation Failure 5 5
Sticking 5 5
Fitting Problem 4 4
Disconnection 4 4
No Apparent Adverse Event 4 4
Therapeutic or Diagnostic Output Failure 4 4
Connection Problem 4 4
Failure to Advance 4 4
Material Integrity Problem 3 3
Bent 3 3
Human-Device Interface Problem 3 3
Contamination /Decontamination Problem 3 3
Metal Shedding Debris 3 3
Activation, Positioning or Separation Problem 3 3
Difficult or Delayed Separation 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Difficult To Position 3 3
Device-Device Incompatibility 3 3
Peeled/Delaminated 3 3
Material Protrusion/Extrusion 3 3
Positioning Failure 2 2
Off-Label Use 2 2
Inaccurate Information 2 2
Device Contamination With Biological Material 2 2
Device Contamination with Chemical or Other Material 2 2
Packaging Problem 2 2
Separation Problem 2 2
Biocompatibility 2 2
Failure to Disconnect 2 2
Degraded 2 2
Physical Property Issue 2 2
Unintended System Motion 2 2
Device Operational Issue 2 2
Material Twisted/Bent 2 2
Material Disintegration 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Inoperable 1 1
Unexpected Therapeutic Results 1 1
Device Appears to Trigger Rejection 1 1
Device Fell 1 1
Compatibility Problem 1 1
Osseointegration Problem 1 1
Corroded 1 1
Measurement System Incompatibility 1 1
Pitted 1 1
Misassembled 1 1
Material Frayed 1 1
Component Misassembled 1 1
Retraction Problem 1 1
Material Puncture/Hole 1 1
Scratched Material 1 1
Difficult or Delayed Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 626 626
No Code Available 562 562
Pain 487 489
Unspecified Infection 406 406
Joint Dislocation 383 383
No Known Impact Or Consequence To Patient 266 266
Joint Disorder 244 244
No Information 201 201
Bone Fracture(s) 176 176
Bacterial Infection 173 173
Fall 143 143
Loss of Range of Motion 76 76
No Consequences Or Impact To Patient 56 56
No Clinical Signs, Symptoms or Conditions 51 51
Limited Mobility Of The Implanted Joint 48 48
Insufficient Information 44 44
Osteolysis 39 39
Tissue Damage 31 31
Injury 29 29
Device Embedded In Tissue or Plaque 29 29
Foreign Body In Patient 28 28
Impaired Healing 19 19
Hematoma 18 18
Muscle/Tendon Damage 18 18
Discomfort 17 17
Swelling 15 15
Reaction 14 14
Joint Laxity 14 14
Inadequate Osseointegration 14 14
Erosion 13 13
Necrosis 12 12
Nerve Damage 12 12
Patient Problem/Medical Problem 12 12
Ossification 11 11
Death 11 11
Post Operative Wound Infection 10 10
Osteopenia/ Osteoporosis 9 9
Not Applicable 9 9
Wound Dehiscence 9 9
Cyst(s) 8 8
Erythema 8 8
Numbness 8 8
Complaint, Ill-Defined 8 8
Fracture, Arm 8 8
Tingling 8 8
Implant Pain 8 8
Ambulation Difficulties 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Sleep Dysfunction 7 7
Unspecified Tissue Injury 7 7
Pneumonia 7 7
Non-union Bone Fracture 6 6
Inflammation 6 6
Irritation 5 5
Weakness 5 5
Fluid Discharge 5 5
No Patient Involvement 5 5
Swelling/ Edema 5 5
Subluxation 4 4
Pneumothorax 4 4
Paralysis 4 4
Toxicity 4 4
Neck Pain 4 4
Distress 4 4
Myocardial Infarction 4 4
Arthritis 4 4
Chest Pain 4 4
Purulent Discharge 3 3
Perforation 3 3
Synovitis 3 3
Urinary Retention 3 3
Unspecified Musculoskeletal problem 3 3
Blood Loss 3 3
Shaking/Tremors 3 3
Sedation 2 2
Tissue Breakdown 2 2
Metal Related Pathology 2 2
Burning Sensation 2 2
Sepsis 2 2
Local Reaction 2 2
Scar Tissue 2 2
Excessive Tear Production 2 2
Arthralgia 2 2
Fever 2 2
Muscular Rigidity 2 2
Connective Tissue Disease 2 2
Cellulitis 2 2
Anemia 2 2
Adhesion(s) 1 1
Radiation Burn 1 1
Calcium Deposits/Calcification 1 1
Stroke/CVA 1 1
Debris, Bone Shedding 1 1
Neuropathy 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Foreign Body Reaction 1 1
Foreign Body Sensation in Eye 1 1
Hypersensitivity/Allergic reaction 1 1
Deformity/ Disfigurement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-23-2018
2 Biomet, Inc. II Dec-05-2012
3 Exactech, Inc. II Jan-18-2024
4 Exactech, Inc. II Oct-03-2018
5 Exactech, Inc. II Dec-22-2016
6 Exactech, Inc. II Jul-31-2012
7 Limacorporate S.p.A II Sep-02-2015
8 Zimmer Biomet, Inc. II Nov-07-2019
9 Zimmer Biomet, Inc. II Dec-29-2017
10 Zimmer Biomet, Inc. II Sep-22-2017
11 Zimmer Inc. II Dec-09-2010
12 Zimmer, Inc. II Feb-26-2014
13 Zimmer, Inc. II Feb-24-2014
14 Zimmer, Inc. II Dec-30-2013
15 Zimmer, Inc. II Aug-26-2013
16 Zimmer, Inc. II Nov-06-2012
17 Zimmer, Inc. II Jun-27-2012
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