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, 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 176 176

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 603 603
Device Dislodged or Dislocated 290 290
Loosening of Implant Not Related to Bone-Ingrowth 183 183
Fracture 156 156
Break 88 88
Appropriate Term/Code Not Available 84 84
Detachment of Device or Device Component 82 82
Insufficient Information 59 59
Naturally Worn 53 53
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
Loss of or Failure to Bond 10 10
Material Erosion 9 9
Inadequacy of Device Shape and/or Size 8 8
Improper or Incorrect Procedure or Method 7 7
Difficult to Insert 7 7
Positioning Problem 7 7
Unintended Movement 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
Activation, Positioning or Separation Problem 3 3
Contamination /Decontamination Problem 3 3
Misassembly by Users 3 3
Therapeutic or Diagnostic Output Failure 3 3
Noise, Audible 3 3
Defective Device 3 3
Microbial Contamination of Device 3 3
Disconnection 3 3
Entrapment of Device 2 2
Material Fragmentation 2 2
Component Missing 2 2
Off-Label Use 2 2
Separation Problem 2 2
Biocompatibility 2 2
Material Integrity Problem 2 2
Material Twisted/Bent 2 2
Inaccurate Information 2 2
Measurement System Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Output Problem 1 1
Connection Problem 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Difficult or Delayed Separation 1 1
Device Fell 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
No Apparent Adverse Event 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
Separation Failure 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 557 557
Joint Dislocation 221 221
Bacterial Infection 176 176
Pain 149 149
Unspecified Infection 115 115
Bone Fracture(s) 105 105
No Known Impact Or Consequence To Patient 79 79
No Code Available 78 78
Insufficient Information 53 53
No Clinical Signs, Symptoms or Conditions 52 52
No Information 43 43
No Consequences Or Impact To Patient 31 31
Loss of Range of Motion 25 25
Muscle/Tendon Damage 23 23
Device Embedded In Tissue or Plaque 19 19
Fall 18 18
Joint Laxity 15 15
Osteolysis 14 14
Limited Mobility Of The Implanted Joint 12 12
Erosion 12 12
Tissue Damage 10 10
Injury 9 9
Inadequate Osseointegration 9 9
Osteopenia/ Osteoporosis 9 9
Impaired Healing 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Implant Pain 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
Non-union Bone Fracture 4 4
Reaction 4 4
Numbness 4 4
Patient Problem/Medical Problem 4 4
Subluxation 4 4
Unspecified Musculoskeletal problem 3 3
Arthralgia 3 3
Blood Loss 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
No Patient Involvement 2 2
Tissue Breakdown 2 2
Metal Related Pathology 2 2
Cognitive Changes 2 2
Constipation 1 1
Not Applicable 1 1
Muscle Hypotonia 1 1
Malunion of Bone 1 1
Decreased Sensitivity 1 1
Ambulation Difficulties 1 1
Hypersensitivity/Allergic reaction 1 1
Tingling 1 1
Fracture, Arm 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
Reaction to Medicinal Component of Device 1 1

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