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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY LNC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 4
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 4
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 3
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 1680 1680
2018 1532 1532
2019 1726 1726
2020 1567 1567
2021 1363 1363
2022 782 882

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2216 2247
Device Dislodged or Dislocated 1476 1519
Insufficient Information 949 949
Appropriate Term/Code Not Available 906 906
Fracture 648 663
Unstable 369 401
Break 368 379
Loosening of Implant Not Related to Bone-Ingrowth 367 369
Loose or Intermittent Connection 311 311
Detachment of Device or Device Component 259 259
Loss of Osseointegration 199 199
Naturally Worn 182 182
Difficult to Insert 177 177
Migration or Expulsion of Device 157 157
Migration 128 141
Loss of or Failure to Bond 98 98
Unintended Movement 72 72
Device Operates Differently Than Expected 71 71
Malposition of Device 55 55
Inadequacy of Device Shape and/or Size 53 53
Noise, Audible 49 49
Osseointegration Problem 46 46
Device Slipped 42 42
Disassembly 41 41
Detachment Of Device Component 39 39
Positioning Failure 39 39
Material Separation 34 34
Material Erosion 34 34
Material Fragmentation 30 30
Device-Device Incompatibility 30 30
Positioning Problem 29 29
Use of Device Problem 29 29
Therapeutic or Diagnostic Output Failure 29 29
Patient Device Interaction Problem 28 28
Patient-Device Incompatibility 26 26
Material Twisted/Bent 24 24
Difficult to Remove 23 23
Device Contaminated During Manufacture or Shipping 23 23
Bent 22 22
Missing Value Reason 22 22
Mechanical Problem 21 21
Material Integrity Problem 21 21
Improper or Incorrect Procedure or Method 20 20
Device Difficult to Setup or Prepare 20 20
Difficult To Position 18 18
Fitting Problem 18 18
Failure To Adhere Or Bond 18 18
Material Deformation 18 18
Mechanical Jam 17 17
Component Missing 17 17
Degraded 15 15
Torn Material 15 15
Packaging Problem 13 13
Scratched Material 13 13
Unintended System Motion 13 13
Contamination 13 13
Inaccurate Information 12 12
Disconnection 12 12
Microbial Contamination of Device 12 12
No Apparent Adverse Event 11 11
Failure to Align 10 10
Corroded 10 10
Failure to Osseointegrate 9 9
Defective Device 9 9
Crack 9 9
Material Split, Cut or Torn 9 9
Metal Shedding Debris 9 9
Dull, Blunt 9 9
Device Issue 8 8
Off-Label Use 8 8
Device Damaged by Another Device 7 7
Physical Resistance/Sticking 7 7
Delivered as Unsterile Product 7 7
Connection Problem 6 6
Separation Problem 6 6
Defective Component 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Disintegration 6 6
Unsealed Device Packaging 6 6
Output Problem 5 5
Entrapment of Device 5 5
Component Falling 5 5
Difficult or Delayed Positioning 5 5
Material Rupture 4 4
Difficult to Advance 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Biocompatibility 4 4
Device Abrasion From Instrument Or Another Object 4 4
Pitted 4 4
Human-Device Interface Problem 4 4
Device Appears to Trigger Rejection 4 4
Device Inoperable 4 4
Sticking 4 4
Device Contamination with Chemical or Other Material 4 4
Unexpected Therapeutic Results 3 3
Device Operational Issue 3 3
Device Packaging Compromised 3 3
Problem with Sterilization 3 3
Contamination /Decontamination Problem 3 3
Misassembled 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1587 1587
Pain 1534 1534
Unspecified Infection 1397 1416
Joint Dislocation 932 947
Failure of Implant 685 692
No Information 579 579
Patient Problem/Medical Problem 455 455
No Known Impact Or Consequence To Patient 452 452
Insufficient Information 442 489
No Clinical Signs, Symptoms or Conditions 367 367
Loss of Range of Motion 339 344
Bone Fracture(s) 310 310
Not Applicable 253 253
Fall 235 235
Injury 207 207
No Consequences Or Impact To Patient 197 197
Inadequate Osseointegration 180 180
Limited Mobility Of The Implanted Joint 165 165
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 159 159
Tissue Damage 137 137
Implant Pain 115 121
Discomfort 99 99
Osteolysis 96 96
Hematoma 93 93
Bacterial Infection 83 83
Joint Laxity 80 81
Joint Disorder 69 69
Swelling 62 62
Erosion 61 61
Muscle Weakness 60 60
Foreign Body In Patient 55 55
Muscular Rigidity 53 53
Numbness 46 46
Ossification 46 46
Ambulation Difficulties 44 44
Reaction 43 43
Nerve Damage 37 37
Device Embedded In Tissue or Plaque 33 33
Foreign Body Reaction 33 33
Tingling 31 31
Osteopenia/ Osteoporosis 31 31
Metal Related Pathology 30 30
Rash 29 29
Muscle/Tendon Damage 27 27
Weakness 27 27
Inflammation 26 26
Arthritis 25 25
Death 25 25
No Patient Involvement 25 25
Synovitis 24 24
Post Operative Wound Infection 23 23
Fracture, Arm 23 23
Adhesion(s) 20 20
Toxicity 18 18
Impaired Healing 17 17
Scar Tissue 16 16
Fever 15 15
Erythema 15 15
Unspecified Tissue Injury 15 15
Pulmonary Embolism 15 15
Fluid Discharge 14 14
Wound Dehiscence 14 14
Paralysis 13 13
Excessive Tear Production 12 12
Hypersensitivity/Allergic reaction 12 12
Sleep Dysfunction 11 11
Rupture 10 10
Abscess 10 10
Hemorrhage/Bleeding 10 10
Damage to Ligament(s) 9 9
Non-union Bone Fracture 9 9
Sepsis 9 9
Thrombus 8 8
Pneumonia 8 8
Myocardial Infarction 8 8
Necrosis 7 7
Unspecified Musculoskeletal problem 7 7
Blood Loss 6 6
Muscle Spasm(s) 6 6
Thrombosis 6 6
Neck Stiffness 5 5
Neurological Deficit/Dysfunction 5 5
Septic Shock 5 5
Tissue Breakdown 5 5
Staphylococcus Aureus 5 5
Fatigue 5 5
Calcium Deposits/Calcification 5 5
Bone Shedding Debris 4 4
Headache 4 4
Atrial Fibrillation 4 4
Purulent Discharge 4 4
Cardiomyopathy 4 4
Twitching 4 4
Debris, Bone Shedding 4 4
Edema 4 4
Subluxation 4 4
Stroke/CVA 3 3
Arthralgia 3 3
Awareness during Anaesthesia 3 3
Irritation 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
15 Zimmer Biomet, Inc. II Jun-01-2017
16 Zimmer Biomet, Inc. II Mar-27-2017
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