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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
CATALYST ORTHOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
FX SHOULDER USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTCAST, GMBH
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
SHOULDER INNOVATIONS INC
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 421 421
2020 216 216
2021 228 228
2022 275 275
2023 384 384
2024 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 577 577
Device Dislodged or Dislocated 282 282
Loosening of Implant Not Related to Bone-Ingrowth 172 172
Fracture 152 152
Break 86 86
Appropriate Term/Code Not Available 84 84
Detachment of Device or Device Component 79 79
Insufficient Information 56 56
Naturally Worn 47 47
Loose or Intermittent Connection 44 44
Unstable 28 28
Patient Device Interaction Problem 18 18
Migration 11 11
Physical Resistance/Sticking 10 10
Patient-Device Incompatibility 10 10
Material Erosion 9 9
Loss of or Failure to Bond 8 8
Inadequacy of Device Shape and/or Size 8 8
Improper or Incorrect Procedure or Method 7 7
Difficult to Insert 7 7
Unintended Movement 7 7
Positioning Problem 7 7
Malposition of Device 6 6
Difficult to Remove 6 6
Material Separation 6 6
Mechanical Problem 6 6
Migration or Expulsion of Device 5 5
Loss of Osseointegration 5 5
Device Slipped 4 4
Mechanical Jam 4 4
Therapeutic or Diagnostic Output Failure 3 3
Activation, Positioning or Separation Problem 3 3
Contamination /Decontamination Problem 3 3
Misassembly by Users 3 3
Noise, Audible 3 3
Microbial Contamination of Device 3 3
Defective Device 3 3
Disconnection 3 3
Entrapment of Device 2 2
Material Fragmentation 2 2
Biocompatibility 2 2
Component Missing 2 2
Off-Label Use 2 2
Separation Problem 2 2
Inaccurate Information 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Measurement System Incompatibility 1 1
Output Problem 1 1
Connection Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult or Delayed Separation 1 1
Device Fell 1 1
No Apparent Adverse Event 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Material Puncture/Hole 1 1
Device Appears to Trigger Rejection 1 1
Fitting Problem 1 1
Dull, Blunt 1 1
Failure to Advance 1 1
Failure to Disconnect 1 1
Material Frayed 1 1
Misassembled 1 1
Material Disintegration 1 1
Device Alarm System 1 1
Corroded 1 1
Degraded 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 531 531
Joint Dislocation 214 214
Bacterial Infection 173 173
Pain 143 143
Unspecified Infection 114 114
Bone Fracture(s) 103 103
No Known Impact Or Consequence To Patient 79 79
No Code Available 78 78
No Clinical Signs, Symptoms or Conditions 49 49
Insufficient Information 43 43
No Information 43 43
No Consequences Or Impact To Patient 31 31
Loss of Range of Motion 24 24
Device Embedded In Tissue or Plaque 19 19
Muscle/Tendon Damage 18 18
Fall 18 18
Joint Laxity 14 14
Osteolysis 13 13
Limited Mobility Of The Implanted Joint 12 12
Tissue Damage 10 10
Erosion 10 10
Injury 9 9
Inadequate Osseointegration 9 9
Osteopenia/ Osteoporosis 9 9
Impaired Healing 8 8
Implant Pain 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Unspecified Tissue Injury 7 7
Foreign Body In Patient 7 7
Wound Dehiscence 7 7
Ossification 6 6
Necrosis 6 6
Post Operative Wound Infection 6 6
Joint Disorder 5 5
Hematoma 5 5
Swelling/ Edema 5 5
Pneumothorax 4 4
Subluxation 4 4
Non-union Bone Fracture 4 4
Reaction 4 4
Numbness 4 4
Patient Problem/Medical Problem 4 4
Blood Loss 3 3
Unspecified Musculoskeletal problem 3 3
Urinary Retention 3 3
Inflammation 3 3
Erythema 3 3
Purulent Discharge 2 2
Connective Tissue Disease 2 2
Anemia 2 2
Arthritis 2 2
Local Reaction 2 2
Swelling 2 2
Nerve Damage 2 2
Metal Related Pathology 2 2
No Patient Involvement 2 2
Tissue Breakdown 2 2
Decreased Sensitivity 1 1
Ambulation Difficulties 1 1
Muscle Hypotonia 1 1
Reaction to Medicinal Component of Device 1 1
Not Applicable 1 1
Malunion of Bone 1 1
Constipation 1 1
Hypersensitivity/Allergic reaction 1 1
Tingling 1 1
Fracture, Arm 1 1
Arthralgia 1 1
Discharge 1 1
Excessive Tear Production 1 1
Discomfort 1 1
Toxicity 1 1
Adhesion(s) 1 1
Radiation Burn 1 1
Calcium Deposits/Calcification 1 1
Stroke/CVA 1 1
Debris, Bone Shedding 1 1
Muscular Rigidity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Jan-18-2024
2 Zimmer Biomet, Inc. II Nov-07-2019
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