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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, shoulder, constrained, metal/metal or metal/polymer cemented
Definition Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96
Product CodeKWR
Regulation Number 888.3640
Device Class 3

MDR Year MDR Reports MDR Events
2015 40 40
2016 25 25
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 32 32
Device Dislodged or Dislocated 13 13
Failure To Adhere Or Bond 7 7
Appropriate Term/Code Not Available 5 5
Fracture 3 3
Migration or Expulsion of Device 3 3
Malposition of Device 3 3
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Loose or Intermittent Connection 1 1
Compatibility Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 18 18
No Code Available 12 12
Bone Fracture(s) 6 6
Unspecified Infection 6 6
Pain 6 6
Failure of Implant 5 5
Insufficient Information 2 2
Fall 2 2
Loss of Range of Motion 2 2
No Consequences Or Impact To Patient 2 2
Fracture, Arm 1 1
Joint Dislocation 1 1
Reaction 1 1
No Known Impact Or Consequence To Patient 1 1
Pulmonary Embolism 1 1
Erosion 1 1
Eructate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 The Anspach Effort, Inc. II Jun-25-2014
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