TPLC - Total Product Life Cycle

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Device	shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis
Definition	A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty.
Product Code	QKW
Regulation Number	888.3695
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	34	35
Device Dislodged or Dislocated	9	9
Migration	3	3
Unstable	2	2
Material Erosion	2	2
Fracture	2	2
Noise, Audible	2	2
Break	1	1
Off-Label Use	1	1
Malposition of Device	1	1
Insufficient Information	1	1
Use of Device Problem	1	1
Device Damaged by Another Device	1	1
Naturally Worn	1	1
Osseointegration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Erosion	15	15
Implant Pain	10	10
Loss of Range of Motion	10	10
Subluxation	8	8
Unspecified Infection	5	5
Insufficient Information	5	6
Damage to Ligament(s)	3	3
Pain	3	3
Muscle/Tendon Damage	3	3
Joint Dislocation	2	2
Joint Laxity	2	2
Bacterial Infection	2	2
Failure of Implant	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Bone Fracture(s)	1	1
Inflammation	1	1
Erythema	1	1
Osteolysis	1	1
Fall	1	1
Tissue Breakdown	1	1