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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
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Product CodeKWS
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 5
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 4
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 9
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2015 1168 1168
2016 966 966
2017 1678 1678
2018 1533 1533
2019 1726 1726
2020 1003 1003

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1772 1772
Device Dislodged or Dislocated 1364 1364
Insufficient Information 1361 1361
Fracture 446 446
Appropriate Term/Code Not Available 433 433
Loose or Intermittent Connection 374 374
Unstable 371 371
Break 318 318
Loosening of Implant Not Related to Bone-Ingrowth 227 227
Migration or Expulsion of Device 196 196
Detachment of Device or Device Component 195 195
Naturally Worn 176 176
Difficult to Insert 171 171
Loss of Osseointegration 170 170
Device Operates Differently Than Expected 165 165
Device Slipped 131 131
Loss of or Failure to Bond 117 117
Detachment Of Device Component 78 78
Screw 76 76
Malposition of Device 72 72
Migration 70 70
Disassembly 67 67
Unintended Movement 63 63
Inadequacy of Device Shape and/or Size 57 57
Mechanical Problem 49 49
Material Separation 47 47
Cuff 46 46
Fitting Problem 44 44
Torn Material 40 40
Noise, Audible 37 37
Plate 37 37
Failure To Adhere Or Bond 35 35
Positioning Problem 34 34
Improper or Incorrect Procedure or Method 33 33
Positioning Failure 30 30
Missing Value Reason 30 30
Tip 29 29
Bent 29 29
Material Erosion 29 29
Osseointegration Problem 29 29
Material Integrity Problem 28 28
Device-Device Incompatibility 28 28
Use of Device Problem 27 27
Patient-Device Incompatibility 27 27
Difficult to Remove 21 21
Component Missing 20 20
Difficult To Position 20 20
Material Deformation 20 20
Material Twisted/Bent 19 19
Mechanical Jam 17 17
Device Contaminated During Manufacture or Shipping 17 17
Contamination 16 16
Disconnection 15 15
Packaging Problem 15 15
Degraded 15 15
Device Difficult to Setup or Prepare 14 14
Metal Shedding Debris 13 13
Material Fragmentation 12 12
Device Damaged by Another Device 12 12
Microbial Contamination of Device 12 12
Therapeutic or Diagnostic Output Failure 12 12
Component Falling 12 12
Scratched Material 12 12
Entrapment of Device 11 11
No Apparent Adverse Event 11 11
Device Issue 11 11
Thread 10 10
Corroded 10 10
Unintended System Motion 10 10
Connection Problem 10 10
Device Inoperable 9 9
Defective Device 9 9
Failure to Align 9 9
Device Subassembly 8 8
Sticking 7 7
Pin 7 7
Failure to Osseointegrate 7 7
Crack 7 7
Device Abrasion From Instrument Or Another Object 6 6
Nonstandard Device 6 6
Material Too Rigid or Stiff 6 6
Human-Device Interface Problem 6 6
Dull, Blunt 6 6
Physical Resistance/Sticking 6 6
Tear, Rip or Hole in Device Packaging 5 5
Incomplete or Missing Packaging 5 5
Unsealed Device Packaging 5 5
Material Disintegration 5 5
Patient Device Interaction Problem 5 5
Material Split, Cut or Torn 5 5
Separation Problem 4 4
Component Incompatible 4 4
Heads 4 4
Off-Label Use 4 4
Pitted 4 4
Device Packaging Compromised 4 4
Component or Accessory Incompatibility 4 4
Defective Component 4 4
Difficult to Advance 4 4
Mechanics Altered 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2048 2048
Pain 1515 1515
Unspecified Infection 1251 1251
No Information 778 778
Joint Dislocation 777 777
Patient Problem/Medical Problem 692 692
No Known Impact Or Consequence To Patient 562 562
Failure of Implant 411 411
Bone Fracture(s) 313 313
Injury 269 269
Loss of Range of Motion 255 255
Not Applicable 254 254
No Consequences Or Impact To Patient 243 243
Fall 233 233
Limited Mobility Of The Implanted Joint 176 176
Inadequate Osseointegration 133 133
Tissue Damage 133 133
Hematoma 91 91
Discomfort 89 89
Osteolysis 77 77
Joint Disorder 76 76
Swelling 66 66
Muscular Rigidity 48 48
Device Embedded In Tissue or Plaque 46 46
Ossification 45 45
Muscle Weakness 44 44
Bacterial Infection 42 42
Erosion 40 40
Reaction 39 39
Death 36 36
Ambulation Difficulties 35 35
Nerve Damage 31 31
Numbness 30 30
Fracture, Arm 29 29
Foreign Body Reaction 28 28
Weakness 28 28
Foreign Body In Patient 27 27
Rash 27 27
No Patient Involvement 24 24
Synovitis 24 24
Arthritis 22 22
Tingling 21 21
Impaired Healing 20 20
Pulmonary Embolism 17 17
Toxicity 16 16
Osteopenia/ Osteoporosis 15 15
Inflammation 14 14
Complaint, Ill-Defined 14 14
Wound Dehiscence 13 13
Excessive Tear Production 12 12
Scar Tissue 12 12
Paralysis 11 11
Fluid Discharge 11 11
Insufficient Information 11 11
Sleep Dysfunction 11 11
Non-union Bone Fracture 10 10
Test Result 9 9
Rupture 9 9
Thrombus 8 8
Abscess 8 8
Staphylococcus Aureus 8 8
Sepsis 8 8
Post Operative Wound Infection 8 8
Damage to Ligament(s) 8 8
Myocardial Infarction 8 8
Adhesion(s) 8 8
Edema 7 7
Blood Loss 7 7
Neurological Deficit/Dysfunction 7 7
Hypersensitivity/Allergic reaction 7 7
Ischemia 6 6
Muscle Spasm(s) 6 6
Neuropathy 6 6
Thrombosis 6 6
Neck Stiffness 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Necrosis 6 6
Laceration(s) 6 6
Pneumonia 5 5
Debris, Bone Shedding 5 5
Septic Shock 5 5
Erythema 5 5
Calcium Deposits/Calcification 5 5
Cardiomyopathy 4 4
Purulent Discharge 4 4
Atrial Fibrillation 4 4
Headache 4 4
Twitching 4 4
Joint Laxity 4 4
Arthralgia 3 3
Joint Swelling 3 3
Therapeutic Response, Decreased 3 3
Rheumatoid Arthritis 3 3
Anemia 3 3
Awareness during Anaesthesia 3 3
Irritation 3 3
Hypoesthesia 3 3
Fever 3 3
Therapeutic Effects, Unexpected 2 2
Cancer 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Apr-03-2020
2 Biomet, Inc. II Feb-24-2015
3 DePuy Orthopaedics, Inc. II Mar-01-2018
4 DePuy Orthopaedics, Inc. II Feb-27-2018
5 Encore Medical, LP II Oct-16-2020
6 Encore Medical, Lp II Mar-28-2018
7 Exactech, Inc. II Jan-18-2018
8 Exactech, Inc. II Apr-20-2015
9 Limacorporate S.p.A II May-25-2016
10 Materialise N.V. II Aug-26-2020
11 Medacta Usa Inc II Jan-03-2020
12 Stryker Howmedica Osteonics Corp. II Aug-10-2015
13 Tornier, Inc II Dec-03-2016
14 Zimmer Biomet, Inc. II Nov-22-2019
15 Zimmer Biomet, Inc. II Mar-01-2019
16 Zimmer Biomet, Inc. II Jun-01-2017
17 Zimmer Biomet, Inc. II Mar-27-2017
18 Zimmer Gmbh II Jun-16-2016
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