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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 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 7
ARTHROSURFACE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSION ORTHOPEDIC
  SUBSTANTIALLY EQUIVALENT 2
ASCENSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEVELAND CLINIC
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY LNC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 6
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 7
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 2
INGEN ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 8
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORPORATION (TORNIER, INC.)
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 5
STRYKER TRAUMA AG
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
TORNIER SAS
  SUBSTANTIALLY EQUIVALENT 7
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 10
TORNIER, SAS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER CAS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1066 1066
2015 1169 1169
2016 970 970
2017 1680 1680
2018 1531 1531
2019 1726 1726
2020 1567 1567
2021 1363 1363
2022 1271 1371
2023 1732 1741
2024 1493 1493

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4655 4701
Device Dislodged or Dislocated 2437 2482
Insufficient Information 1778 1778
Fracture 1216 1231
Appropriate Term/Code Not Available 1044 1044
Unstable 719 755
Break 679 690
Loosening of Implant Not Related to Bone-Ingrowth 535 537
Loose or Intermittent Connection 520 520
Detachment of Device or Device Component 346 346
Naturally Worn 310 310
Loss of Osseointegration 283 283
Migration or Expulsion of Device 231 231
Device Operates Differently Than Expected 227 227
Migration 218 231
Difficult to Insert 204 204
Device Slipped 197 197
Osseointegration Problem 173 183
Loss of or Failure to Bond 164 164
Malposition of Device 131 131
Inadequacy of Device Shape and/or Size 96 96
Detachment Of Device Component 89 89
Disassembly 87 87
Unintended Movement 81 81
Material Separation 80 80
Patient Device Interaction Problem 75 75
Noise, Audible 71 71
Fitting Problem 64 64
Mechanical Problem 62 62
Torn Material 54 54
Positioning Problem 53 53
Material Integrity Problem 51 51
Material Erosion 45 45
Positioning Failure 45 45
Improper or Incorrect Procedure or Method 41 41
Use of Device Problem 41 41
Material Fragmentation 39 39
Mechanical Jam 38 38
Failure To Adhere Or Bond 38 38
Material Twisted/Bent 38 38
Difficult to Remove 35 35
Device-Device Incompatibility 35 35
Therapeutic or Diagnostic Output Failure 34 34
Bent 33 33
Patient-Device Incompatibility 33 33
Missing Value Reason 30 30
Degraded 29 29
Failure to Osseointegrate 29 29
Material Deformation 28 28
No Apparent Adverse Event 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 2533 2557
No Code Available 2516 2516
Pain 2245 2245
Joint Dislocation 1602 1639
Failure of Implant 1232 1239
No Information 976 976
No Clinical Signs, Symptoms or Conditions 835 835
Insufficient Information 784 831
Patient Problem/Medical Problem 695 695
No Known Impact Or Consequence To Patient 632 632
Bone Fracture(s) 589 599
Loss of Range of Motion 527 532
Joint Laxity 477 499
Fall 434 434
Implant Pain 430 436
Inadequate Osseointegration 328 338
Injury 278 278
No Consequences Or Impact To Patient 267 267
Not Applicable 252 252
Limited Mobility Of The Implanted Joint 213 213
Osteolysis 198 198
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 191 191
Tissue Damage 155 155
Bacterial Infection 151 151
Limb Fracture 150 150
Discomfort 147 147
Hematoma 117 117
Erosion 107 107
Foreign Body In Patient 97 97
Ossification 95 95
Joint Disorder 78 78
Muscle/Tendon Damage 77 83
Swelling 73 73
Muscle Weakness 65 65
Numbness 57 57
Nerve Damage 57 57
Muscular Rigidity 57 57
Metal Related Pathology 57 57
Ambulation Difficulties 56 56
Device Embedded In Tissue or Plaque 56 56
Osteopenia/ Osteoporosis 54 54
Foreign Body Reaction 50 50
Subluxation 46 46
Reaction 45 45
Inflammation 44 44
Hypersensitivity/Allergic reaction 40 40
Unspecified Tissue Injury 39 39
Death 38 38
Swelling/ Edema 36 36
Arthritis 35 35

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II Apr-03-2020
3 Biomet, Inc. II Feb-24-2015
4 Biomet, Inc. II Jan-09-2013
5 Biomet, Inc. II Jun-09-2011
6 Biomet, Inc. II Dec-16-2010
7 DePuy Orthopaedics, Inc. II Mar-01-2018
8 DePuy Orthopaedics, Inc. II Feb-27-2018
9 Depuy Orthopaedics, Inc. II Jan-15-2009
10 Encore Medical, LP II Nov-08-2023
11 Encore Medical, LP II Sep-19-2023
12 Encore Medical, LP II Aug-23-2021
13 Encore Medical, LP II Oct-16-2020
14 Encore Medical, Lp II Mar-28-2018
15 Encore Medical, Lp II Jul-06-2011
16 Encore Medical, Lp II Dec-22-2010
17 Exactech, Inc. II Mar-29-2024
18 Exactech, Inc. II Jan-18-2024
19 Exactech, Inc. II Nov-17-2020
20 Exactech, Inc. II Jan-18-2018
21 Exactech, Inc. II Apr-20-2015
22 Exactech, Inc. II Jul-31-2012
23 Integra LifeSciences Corp. II Nov-08-2014
24 Limacorporate S.p.A II May-25-2016
25 Materialise N.V. II Aug-26-2020
26 Medacta Usa Inc II Jan-03-2020
27 Smith & Nephew Inc II Apr-07-2010
28 Smith & Nephew Inc II Feb-03-2009
29 Stryker Howmedica Osteonics Corp. II Aug-10-2015
30 Stryker Howmedica Osteonics Corp. II Jan-26-2009
31 Tornier, Inc II Jun-28-2023
32 Tornier, Inc II Jul-12-2021
33 Tornier, Inc II Dec-03-2016
34 Tournier, Inc. II Jan-23-2009
35 Zimmer Biomet, Inc. II Nov-22-2019
36 Zimmer Biomet, Inc. II Mar-01-2019
37 Zimmer Biomet, Inc. II Jun-01-2017
38 Zimmer Biomet, Inc. II Mar-27-2017
39 Zimmer Gmbh II Jun-16-2016
40 Zimmer, Inc. II Nov-06-2012
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