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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 176 176

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1023 1023
Device Dislodged or Dislocated 623 623
Insufficient Information 390 390
Fracture 306 306
Loosening of Implant Not Related to Bone-Ingrowth 229 229
Loose or Intermittent Connection 213 213
Break 173 173
Appropriate Term/Code Not Available 160 160
Unstable 111 111
Detachment of Device or Device Component 106 106
Naturally Worn 106 106
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 33 33
Failure To Adhere Or Bond 28 28
Improper or Incorrect Procedure or Method 28 28
Mechanical Jam 26 26
Patient Device Interaction Problem 22 22
Material Separation 22 22
Difficult to Insert 20 20
Malposition of Device 19 19
Patient-Device Incompatibility 18 18
Inadequacy of Device Shape and/or Size 16 16
Difficult to Remove 16 16
Positioning Problem 15 15
Physical Resistance/Sticking 14 14
Material Erosion 14 14
Loss of Osseointegration 14 14
Mechanical Problem 13 13
Unintended Movement 13 13
Disassembly 12 12
Microbial Contamination of Device 12 12
Contamination 11 11
Torn Material 9 9
Material Deformation 9 9
Noise, Audible 8 8
Component Missing 8 8
Dull, Blunt 7 7
Material Fragmentation 7 7
Entrapment of Device 7 7
Separation Failure 6 6
Material Split, Cut or Torn 6 6
Misassembly by Users 5 5
Defective Device 5 5
Use of Device Problem 5 5
Sticking 5 5
Component Falling 5 5
Disconnection 4 4
Fitting Problem 4 4
Failure to Advance 4 4
Connection Problem 4 4
No Apparent Adverse Event 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Integrity Problem 3 3
Material Protrusion/Extrusion 3 3
Human-Device Interface Problem 3 3
Contamination /Decontamination Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Difficult or Delayed Separation 3 3
Activation, Positioning or Separation Problem 3 3
Device-Device Incompatibility 3 3
Metal Shedding Debris 3 3
Bent 3 3
Peeled/Delaminated 3 3
Difficult To Position 3 3
Off-Label Use 2 2
Unintended System Motion 2 2
Material Disintegration 2 2
Degraded 2 2
Positioning Failure 2 2
Failure to Disconnect 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Contamination with Chemical or Other Material 2 2
Device Operational Issue 2 2
Device Contamination With Biological Material 2 2
Biocompatibility 2 2
Inaccurate Information 2 2
Separation Problem 2 2
Packaging Problem 2 2
Physical Property Issue 2 2
Material Twisted/Bent 2 2
Measurement System Incompatibility 1 1
Compatibility Problem 1 1
Incorrect Device Or Component Shipped 1 1
Device Contaminated During Manufacture or Shipping 1 1
Osseointegration Problem 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Temperature Problem 1 1
Device Fell 1 1
Component Misassembled 1 1
Difficult or Delayed Activation 1 1
Device Damaged by Another Device 1 1
Difficult to Advance 1 1
Device Damaged Prior to Use 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 652 652
No Code Available 562 562
Pain 493 495
Unspecified Infection 407 407
Joint Dislocation 390 390
No Known Impact Or Consequence To Patient 266 266
Joint Disorder 244 244
No Information 201 201
Bone Fracture(s) 178 178
Bacterial Infection 176 176
Fall 143 143
Loss of Range of Motion 77 77
No Consequences Or Impact To Patient 56 56
Insufficient Information 54 54
No Clinical Signs, Symptoms or Conditions 54 54
Limited Mobility Of The Implanted Joint 48 48
Osteolysis 40 40
Tissue Damage 31 31
Injury 29 29
Device Embedded In Tissue or Plaque 29 29
Foreign Body In Patient 28 28
Muscle/Tendon Damage 23 23
Impaired Healing 19 19
Hematoma 18 18
Discomfort 17 17
Swelling 15 15
Erosion 15 15
Joint Laxity 15 15
Inadequate Osseointegration 14 14
Reaction 14 14
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
Ambulation Difficulties 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Implant Pain 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
Arthralgia 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
Cognitive Changes 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
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

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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