Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, shoulder, semi-constrained, metal/polymer cemented
Product CodeKWS
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 4
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY LNC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 4
TECHMAH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 2
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 1532 1532
2019 1726 1726
2020 1567 1567
2021 1364 1364
2022 1298 1398
2023 617 617

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2516 2547
Device Dislodged or Dislocated 1274 1317
Appropriate Term/Code Not Available 835 835
Fracture 747 762
Insufficient Information 588 588
Loosening of Implant Not Related to Bone-Ingrowth 401 403
Break 348 359
Detachment of Device or Device Component 284 284
Unstable 278 310
Loose or Intermittent Connection 238 238
Loss of Osseointegration 200 200
Naturally Worn 180 180
Migration 175 188
Difficult to Insert 131 131
Migration or Expulsion of Device 85 85
Osseointegration Problem 84 84
Loss of or Failure to Bond 81 81
Unintended Movement 73 73
Malposition of Device 63 63
Patient Device Interaction Problem 52 52
Noise, Audible 45 45
Inadequacy of Device Shape and/or Size 44 44
Positioning Failure 40 40
Material Fragmentation 34 34
Material Erosion 32 32
Therapeutic or Diagnostic Output Failure 29 29
Positioning Problem 28 28
Material Separation 27 27
Use of Device Problem 26 26
Device Slipped 25 25
Device-Device Incompatibility 25 25
Material Twisted/Bent 24 24
Device Contaminated During Manufacture or Shipping 23 23
Difficult to Remove 23 23
Mechanical Jam 22 22
Device Operates Differently Than Expected 21 21
Material Integrity Problem 20 20
Device Difficult to Setup or Prepare 20 20
Component Missing 18 18
Patient-Device Incompatibility 16 16
Degraded 15 15
Inaccurate Information 15 15
Material Deformation 14 14
Disassembly 14 14
Detachment Of Device Component 14 14
Mechanical Problem 14 14
Unintended System Motion 13 13
Crack 13 13
No Apparent Adverse Event 13 13
Packaging Problem 12 12
Failure to Osseointegrate 12 12
Failure to Align 11 11
Dull, Blunt 11 11
Defective Device 10 10
Microbial Contamination of Device 10 10
Disconnection 10 10
Corroded 10 10
Scratched Material 9 9
Material Split, Cut or Torn 9 9
Improper or Incorrect Procedure or Method 8 8
Fitting Problem 8 8
Off-Label Use 8 8
Difficult To Position 8 8
Physical Resistance/Sticking 7 7
Separation Problem 6 6
Output Problem 6 6
Contamination /Decontamination Problem 6 6
Delivered as Unsterile Product 6 6
Tear, Rip or Hole in Device Packaging 6 6
Entrapment of Device 6 6
Unsealed Device Packaging 5 5
Difficult or Delayed Positioning 5 5
Failure To Adhere Or Bond 5 5
Device Issue 5 5
Defective Component 5 5
Device Damaged by Another Device 5 5
Difficult to Advance 4 4
Connection Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Biocompatibility 4 4
Material Rupture 4 4
Device Appears to Trigger Rejection 4 4
Contamination 4 4
Material Disintegration 4 4
Bent 3 3
Misassembled 3 3
Problem with Sterilization 3 3
Metal Shedding Debris 3 3
Human-Device Interface Problem 3 3
Installation-Related Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Device Packaging Compromised 2 2
Mechanics Altered 2 2
Device Fell 2 2
Ejection Problem 2 2
Device Handling Problem 2 2
Failure to Advance 2 2
Unexpected Therapeutic Results 2 2
Device Inoperable 2 2
Material Invagination 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1341 1360
Pain 1316 1316
No Code Available 1224 1224
Joint Dislocation 914 929
Failure of Implant 722 729
No Clinical Signs, Symptoms or Conditions 536 536
Insufficient Information 527 574
No Information 380 380
No Known Impact Or Consequence To Patient 342 342
Bone Fracture(s) 326 326
Loss of Range of Motion 318 323
Patient Problem/Medical Problem 305 305
Not Applicable 253 253
Inadequate Osseointegration 211 211
Implant Pain 203 209
Fall 193 193
Joint Laxity 184 185
Injury 184 184
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 180 180
No Consequences Or Impact To Patient 158 158
Osteolysis 127 127
Limited Mobility Of The Implanted Joint 115 115
Bacterial Infection 106 106
Hematoma 99 99
Tissue Damage 97 97
Discomfort 90 90
Erosion 78 78
Foreign Body In Patient 70 70
Swelling 60 60
Muscle Weakness 55 55
Muscular Rigidity 50 50
Joint Disorder 50 50
Muscle/Tendon Damage 45 45
Ambulation Difficulties 44 44
Ossification 43 43
Metal Related Pathology 40 40
Reaction 39 39
Numbness 39 39
Inflammation 34 34
Osteopenia/ Osteoporosis 32 32
Rash 29 29
Arthritis 27 27
Foreign Body Reaction 27 27
Unspecified Tissue Injury 26 26
Nerve Damage 25 25
Tingling 25 25
Device Embedded In Tissue or Plaque 24 24
Post Operative Wound Infection 23 23
Fluid Discharge 22 22
Adhesion(s) 22 22
Hypersensitivity/Allergic reaction 21 21
No Patient Involvement 20 20
Fracture, Arm 20 20
Toxicity 18 18
Limb Fracture 18 18
Scar Tissue 18 18
Synovitis 18 18
Non-union Bone Fracture 17 17
Fever 16 16
Pulmonary Embolism 15 15
Impaired Healing 15 15
Wound Dehiscence 14 14
Swelling/ Edema 14 14
Erythema 13 13
Hemorrhage/Bleeding 13 13
Death 12 12
Sepsis 11 11
Subluxation 11 11
Weakness 10 10
Sleep Dysfunction 9 9
Cyst(s) 9 9
Abscess 9 9
Damage to Ligament(s) 8 8
Rupture 8 8
Arthralgia 8 8
Thrombus 7 7
Seroma 7 7
Unspecified Musculoskeletal problem 7 7
Pneumonia 6 6
Blood Loss 6 6
Excessive Tear Production 5 5
Loss of consciousness 5 5
Neurological Deficit/Dysfunction 5 5
Septic Shock 5 5
Calcium Deposits/Calcification 5 5
Fatigue 5 5
Edema 4 4
Atrial Fibrillation 4 4
Memory Loss/Impairment 4 4
Muscle Spasm(s) 4 4
Paralysis 4 4
Tissue Breakdown 4 4
Peripheral Nervous Injury 4 4
Bone Shedding Debris 4 4
Malunion of Bone 3 3
Hypoesthesia 3 3
Perforation 3 3
Thrombosis 3 3
Irritation 3 3
Myocardial Infarction 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II Apr-03-2020
3 DePuy Orthopaedics, Inc. II Mar-01-2018
4 DePuy Orthopaedics, Inc. II Feb-27-2018
5 Encore Medical, LP II Aug-23-2021
6 Encore Medical, LP II Oct-16-2020
7 Encore Medical, Lp II Mar-28-2018
8 Exactech, Inc. II Nov-17-2020
9 Exactech, Inc. II Jan-18-2018
10 Materialise N.V. II Aug-26-2020
11 Medacta Usa Inc II Jan-03-2020
12 Tornier, Inc II Jul-12-2021
13 Zimmer Biomet, Inc. II Nov-22-2019
14 Zimmer Biomet, Inc. II Mar-01-2019
-
-