TPLC - Total Product Life Cycle

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Device	prosthesis, shoulder, hemi-, humeral, metallic uncemented
Product Code	HSD
Regulation Number	888.3690
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1813	1813
Device Dislodged or Dislocated	534	534
Fracture	234	234
Osseointegration Problem	166	166
Appropriate Term/Code Not Available	159	159
Break	131	131
Difficult to Insert	108	108
Loss of Osseointegration	105	105
Naturally Worn	84	84
Insufficient Information	80	80
Detachment of Device or Device Component	80	80
Loosening of Implant Not Related to Bone-Ingrowth	76	76
Loss of or Failure to Bond	70	70
Patient Device Interaction Problem	54	54
Migration	45	45
Unstable	37	37
Use of Device Problem	18	18
Device-Device Incompatibility	18	18
Material Deformation	17	17
Loose or Intermittent Connection	17	17
Off-Label Use	15	15
Malposition of Device	15	15
Noise, Audible	13	13
Manufacturing, Packaging or Shipping Problem	12	12
Device Damaged Prior to Use	11	11
Material Erosion	11	11
Packaging Problem	10	10
Crack	9	9
Inadequacy of Device Shape and/or Size	9	9
Inaccurate Information	9	9
Fitting Problem	8	8
Positioning Failure	8	8
Difficult to Advance	8	8
Tear, Rip or Hole in Device Packaging	8	8
Patient-Device Incompatibility	6	6
Therapeutic or Diagnostic Output Failure	6	6
Material Twisted/Bent	6	6
Migration or Expulsion of Device	6	6
Material Split, Cut or Torn	6	6
Mechanical Problem	5	5
Device Appears to Trigger Rejection	5	5
Difficult to Remove	5	5
Mechanical Jam	5	5
Positioning Problem	5	5
Device Markings/Labelling Problem	5	5
Failure to Advance	5	5
Separation Failure	3	3
Microbial Contamination of Device	3	3
Component Missing	3	3
Contamination /Decontamination Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	898	898
No Code Available	866	866
Pain	765	765
Joint Dislocation	424	424
No Clinical Signs, Symptoms or Conditions	287	287
Inadequate Osseointegration	247	247
Joint Laxity	225	225
Insufficient Information	197	197
Bone Fracture(s)	179	179
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	175	175
Failure of Implant	166	166
Unspecified Tissue Injury	158	158
Loss of Range of Motion	156	156
Hematoma	81	81
No Consequences Or Impact To Patient	78	78
Not Applicable	78	78
No Information	75	75
No Known Impact Or Consequence To Patient	67	67
Limited Mobility Of The Implanted Joint	56	56
Injury	54	54
Discomfort	52	52
Muscular Rigidity	47	47
Osteolysis	45	45
Fall	41	41
Nerve Damage	35	35
Foreign Body Reaction	29	29
Implant Pain	27	27
Muscle/Tendon Damage	25	25
Tissue Damage	25	25
Ossification	24	24
Unspecified Musculoskeletal problem	22	22
Inflammation	21	21
Adhesion(s)	20	20
Stroke/CVA	19	19
Hypersensitivity/Allergic reaction	18	18
Bacterial Infection	18	18
Pneumonia	14	14
Erosion	13	13
Foreign Body In Patient	13	13
Fatigue	12	12
Subluxation	12	12
Numbness	12	12
Scar Tissue	12	12
Sepsis	11	11
Metal Related Pathology	11	11
Pulmonary Embolism	11	11
No Patient Involvement	11	11
Joint Disorder	9	9
Death	9	9
Osteopenia/ Osteoporosis	9	9