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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 + additive, cemented
Regulation Description Shoulder joint metal/polymer semi-constrained cemented prosthesis.
Definition Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Product CodePAO
Regulation Number 888.3660
Device Class 2


Premarket Reviews
ManufacturerDecision
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 63 63
2017 176 176
2018 93 93
2019 17 17
2020 7 7
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 103 103
Device Dislodged or Dislocated 60 60
Fracture 56 56
Difficult to Insert 39 39
Unstable 28 28
Migration or Expulsion of Device 19 19
Adverse Event Without Identified Device or Use Problem 18 18
Detachment Of Device Component 10 10
Difficult To Position 9 9
Appropriate Term/Code Not Available 9 9
Device-Device Incompatibility 8 8
Naturally Worn 7 7
Device Operates Differently Than Expected 7 7
Fitting Problem 6 6
Malposition of Device 5 5
Material Erosion 5 5
Loose or Intermittent Connection 5 5
Detachment of Device or Device Component 5 5
Device Damaged by Another Device 5 5
Noise, Audible 4 4
Disassembly 4 4
Bent 4 4
Break 3 3
Mechanical Problem 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Packaging Problem 3 3
Off-Label Use 2 2
Patient-Device Incompatibility 2 2
Component or Accessory Incompatibility 2 2
Contamination 2 2
Difficult or Delayed Positioning 2 2
Material Deformation 2 2
Compatibility Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Failure To Adhere Or Bond 1 1
Misassembled 1 1
Delivered as Unsterile Product 1 1
Positioning Problem 1 1
Scratched Material 1 1
Device Emits Odor 1 1
Unsealed Device Packaging 1 1
Device Operational Issue 1 1
Material Separation 1 1
Metal Shedding Debris 1 1
Incomplete or Missing Packaging 1 1
Failure to Align 1 1
Separation Failure 1 1
Temperature Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 99 99
No Information 63 63
Joint Dislocation 62 62
No Code Available 53 53
No Known Impact Or Consequence To Patient 37 37
Unspecified Infection 33 33
Loss of Range of Motion 28 28
No Consequences Or Impact To Patient 18 18
Limited Mobility Of The Implanted Joint 10 10
Reaction 9 9
Failure of Implant 6 6
Foreign Body Reaction 5 5
Bone Fracture(s) 5 5
Tissue Damage 5 5
Foreign Body In Patient 5 5
Scar Tissue 4 4
Ambulation Difficulties 4 4
Fall 4 4
Bacterial Infection 3 3
No Patient Involvement 3 3
Tissue Breakdown 3 3
Sleep Dysfunction 3 3
Swelling 3 3
Injury 2 2
Weakness 2 2
Numbness 2 2
Erosion 2 2
Headache 2 2
Hematoma 2 2
Nerve Damage 2 2
Paralysis 2 2
Perforation 1 1
Abscess 1 1
Inflammation 1 1
Burn(s) 1 1
Cyst(s) 1 1
Death 1 1
Fracture, Arm 1 1
Rupture 1 1
Urinary Tract Infection 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Muscle/Tendon Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Zimmer Biomet, Inc. I Feb-11-2017
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