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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

Device Problems
Adverse Event Without Identified Device or Use Problem 1413
Insufficient Information 1072
Device Dislodged or Dislocated 796
Fracture 315
Unstable 185
Migration or Expulsion of Device 180
Loosening of Implant Not Related to Bone-Ingrowth 160
Difficult to Insert 159
Loss of Osseointegration 155
Detachment of Device or device Component 146
Naturally Worn 111
Loss of or Failure to Bond 107
Appropriate Term/Code Not Available 93
Break 88
Migration 63
Loose or Intermittent Connection 62
Disassembly 57
Unintended Movement 55
Device Operates Differently Than Expected 46
Malposition of device 46
Mechanical Problem 43
Detachment Of Device Component 37
Fitting Problem 30
Missing Value Reason 30
Bent 28
Inadequacy of Device Shape and/or Size 28
Osseointegration Problem 28
Material Integrity Problem 26
Material Erosion 25
Noise, Audible 25
Device-Device Incompatibility 25
Device Slipped 25
Positioning Failure 23
Material Separation 22
Difficult To Position 19
Material Deformation 18
Use of Device Problem 17
Positioning Problem 16
Device Contaminated during manufacture or shipping 14
Packaging Problem 13
Device Difficult to Setup or Prepare 13
Disconnection 12
Scratched Material 12
Device Damaged by Another Device 12
Material Twisted / Bent 12
Device Issue 11
No Apparent Adverse Event 11
Corroded 10
Material Fragmentation 10
Mechanical Jam 10
Unintended System Motion 10
Screw 9
Failure To Adhere Or Bond 8
Degraded 8
Difficult to Remove 8
Component Missing 8
Improper or Incorrect Procedure or Method 7
Patient-Device Incompatibility 7
Failure to Align 6
Plate 6
Device Abrasion From Instrument Or Another Object 6
Torn Material 6
Cuff 6
Dull, Blunt 6
Failure to Osseointegrate 6
Patient Device Interaction Problem 5
Defective Device 5
Unsealed Device Packaging 5
Connection Problem 5
Human-Device Interface Problem 4
Off-Label Use 4
Component or Accessory Incompatibility 4
Pitted 4
Guidewire 3
Failure to Advance 3
Material Disintegration 3
Tear, Rip or Hole in Device Packaging 3
Delivered as Unsterile Product 3
Physical Resistance / Sticking 3
Separation Problem 3
Device Operational Issue 3
Entrapment of Device 3
Separation Failure 3
Device Packaging Compromised 3
Material Distortion 3
Device Inoperable 2
Incomplete or Missing Packaging 2
Activation, Positioning or Separation Problem 2
Unintended Collision 2
Contamination During Use 2
Manufacturing, Packaging or Shipping Problem 2
Defective Component 2
Device Reprocessing Problem 2
Device Contamination with Chemical or Other Material 2
Metal Shedding Debris 2
Crack 2
Component Falling 2
Difficult to Advance 2
Compatibility Problem 2
Tip 2
Total Device Problems 6123

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 Mar-28-2018
6 Exactech, Inc. II Jan-18-2018
7 Exactech, Inc. II Apr-20-2015
8 Limacorporate S.p.A II May-25-2016
9 Medacta Usa Inc II Jan-03-2020
10 Stryker Howmedica Osteonics Corp. II Aug-10-2015
11 Tornier, Inc II Dec-03-2016
12 Zimmer Biomet, Inc. II Nov-22-2019
13 Zimmer Biomet, Inc. II Mar-01-2019
14 Zimmer Biomet, Inc. II Jun-01-2017
15 Zimmer Biomet, Inc. II Mar-27-2017
16 Zimmer Gmbh II Jun-16-2016

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