TPLC - Total Product Life Cycle

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Device	prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
Definition	Replacement of the humeral head for total anatomic shoulder arthroplasty
Product Code	PKC
Regulation Number	888.3660
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	54	54
Device Dislodged or Dislocated	22	22
Appropriate Term/Code Not Available	20	20
Insufficient Information	6	6
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Migration	3	3
Patient Device Interaction Problem	3	3
Naturally Worn	3	3
No Apparent Adverse Event	3	3
Difficult to Remove	3	3
Inadequacy of Device Shape and/or Size	2	2
Fracture	2	2
Osseointegration Problem	2	2
Material Split, Cut or Torn	2	2
Physical Resistance/Sticking	1	1
Output Problem	1	1
Material Twisted/Bent	1	1
Mechanical Jam	1	1
Noise, Audible	1	1
Loose or Intermittent Connection	1	1
Migration or Expulsion of Device	1	1
Failure To Adhere Or Bond	1	1
Degraded	1	1
Unstable	1	1
Use of Device Problem	1	1
Device-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	22	22
Pain	18	18
Unspecified Infection	15	15
Implant Pain	11	11
Joint Dislocation	10	10
Failure of Implant	9	9
Joint Laxity	8	8
Unspecified Tissue Injury	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
No Information	6	6
No Clinical Signs, Symptoms or Conditions	5	5
Metal Related Pathology	5	5
Arthralgia	5	5
Loss of Range of Motion	4	4
Osteolysis	3	3
No Code Available	2	2
Limb Fracture	2	2
Bacterial Infection	2	2
Cardiac Arrest	2	2
Fall	2	2
Unspecified Musculoskeletal problem	2	2
Swelling/ Edema	2	2
Muscle/Tendon Damage	1	1
Hypersensitivity/Allergic reaction	1	1
Erosion	1	1
Toxicity	1	1
Muscular Rigidity	1	1
Subluxation	1	1
Inadequate Osseointegration	1	1
Limited Mobility Of The Implanted Joint	1	1
No Known Impact Or Consequence To Patient	1	1