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	1798	1798
Device Dislodged or Dislocated	530	530
Fracture	230	230
Osseointegration Problem	166	166
Appropriate Term/Code Not Available	159	159
Break	130	130
Difficult to Insert	108	108
Loss of Osseointegration	106	106
Naturally Worn	82	82
Detachment of Device or Device Component	80	80
Insufficient Information	80	80
Loosening of Implant Not Related to Bone-Ingrowth	77	77
Loss of or Failure to Bond	70	70
Patient Device Interaction Problem	49	49
Migration	44	44
Unstable	36	36
Device-Device Incompatibility	18	18
Use of Device Problem	18	18
Loose or Intermittent Connection	17	17
Material Deformation	17	17
Off-Label Use	15	15
Malposition of Device	15	15
Noise, Audible	13	13
Manufacturing, Packaging or Shipping Problem	12	12
Material Erosion	11	11
Device Damaged Prior to Use	10	10
Packaging Problem	10	10
Inaccurate Information	9	9
Inadequacy of Device Shape and/or Size	9	9
Crack	8	8
Difficult to Advance	8	8
Tear, Rip or Hole in Device Packaging	8	8
Positioning Failure	8	8
Fitting Problem	7	7
Material Split, Cut or Torn	6	6
Material Twisted/Bent	6	6
Migration or Expulsion of Device	6	6
Therapeutic or Diagnostic Output Failure	6	6
Patient-Device Incompatibility	6	6
Difficult to Remove	5	5
Mechanical Jam	5	5
Device Appears to Trigger Rejection	5	5
Positioning Problem	5	5
Mechanical Problem	5	5
Failure to Advance	5	5
Device Markings/Labelling Problem	5	5
Corroded	3	3
Device Slipped	3	3
Connection Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	891	891
No Code Available	866	866
Pain	760	760
Joint Dislocation	420	420
No Clinical Signs, Symptoms or Conditions	280	280
Inadequate Osseointegration	245	245
Joint Laxity	224	224
Insufficient Information	197	197
Bone Fracture(s)	179	179
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	175	175
Failure of Implant	165	165
Loss of Range of Motion	154	154
Unspecified Tissue Injury	153	153
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	40	40
Nerve Damage	35	35
Foreign Body Reaction	29	29
Muscle/Tendon Damage	26	26
Implant Pain	26	26
Tissue Damage	25	25
Ossification	24	24
Unspecified Musculoskeletal problem	22	22
Adhesion(s)	20	20
Inflammation	20	20
Stroke/CVA	19	19
Hypersensitivity/Allergic reaction	19	19
Bacterial Infection	18	18
Pneumonia	14	14
Erosion	13	13
Foreign Body In Patient	13	13
Subluxation	12	12
Scar Tissue	12	12
Fatigue	12	12
Numbness	12	12
Pulmonary Embolism	11	11
Sepsis	11	11
No Patient Involvement	11	11
Metal Related Pathology	10	10
Osteopenia/ Osteoporosis	9	9
Death	9	9
Post Operative Wound Infection	9	9