TPLC - Total Product Life Cycle

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Device	prosthesis, shoulder, non-constrained, metal/polymer cemented
Product Code	KWT
Regulation Number	888.3650
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	660	660
Device Dislodged or Dislocated	327	327
Loosening of Implant Not Related to Bone-Ingrowth	203	203
Fracture	171	171
Detachment of Device or Device Component	112	112
Break	98	98
Appropriate Term/Code Not Available	85	85
Naturally Worn	64	64
Insufficient Information	63	63
Loose or Intermittent Connection	44	44
Unstable	36	36
Patient Device Interaction Problem	18	18
Migration	13	13
Loss of or Failure to Bond	11	11
Physical Resistance/Sticking	10	10
Material Erosion	10	10
Patient-Device Incompatibility	10	10
Inadequacy of Device Shape and/or Size	10	10
Unintended Movement	8	8
Improper or Incorrect Procedure or Method	7	7
Difficult to Insert	7	7
Positioning Problem	7	7
Mechanical Problem	6	6
Malposition of Device	6	6
Material Separation	6	6
Difficult to Remove	6	6
Loss of Osseointegration	5	5
Migration or Expulsion of Device	5	5
Device Slipped	4	4
Mechanical Jam	4	4
Noise, Audible	3	3
Misassembly by Users	3	3
Contamination /Decontamination Problem	3	3
Microbial Contamination of Device	3	3
Disconnection	3	3
Therapeutic or Diagnostic Output Failure	3	3
Defective Device	3	3
Activation, Positioning or Separation Problem	3	3
Material Integrity Problem	2	2
Material Fragmentation	2	2
Biocompatibility	2	2
Fitting Problem	2	2
Component Missing	2	2
Material Twisted/Bent	2	2
Inaccurate Information	2	2
Separation Problem	2	2
Entrapment of Device	2	2
Off-Label Use	2	2
Dull, Blunt	1	1
Osseointegration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	593	593
Joint Dislocation	252	252
Pain	183	183
Bacterial Infection	178	178
Unspecified Infection	129	129
Bone Fracture(s)	114	114
Insufficient Information	99	99
No Known Impact Or Consequence To Patient	79	79
No Code Available	78	78
No Clinical Signs, Symptoms or Conditions	66	66
No Information	43	43
No Consequences Or Impact To Patient	31	31
Loss of Range of Motion	27	27
Muscle/Tendon Damage	26	26
Fall	22	22
Device Embedded In Tissue or Plaque	19	19
Joint Laxity	19	19
Osteolysis	17	17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Erosion	12	12
Limited Mobility Of The Implanted Joint	12	12
Implant Pain	12	12
Wound Dehiscence	11	11
Unspecified Tissue Injury	11	11
Tissue Damage	10	10
Inadequate Osseointegration	10	10
Necrosis	10	10
Injury	9	9
Osteopenia/ Osteoporosis	9	9
Impaired Healing	8	8
Ossification	7	7
Foreign Body In Patient	7	7
Subluxation	6	6
Swelling/ Edema	6	6
Post Operative Wound Infection	6	6
Hematoma	5	5
Joint Disorder	5	5
Numbness	4	4
Nerve Damage	4	4
Reaction	4	4
Non-union Bone Fracture	4	4
Metal Related Pathology	4	4
Pneumothorax	4	4
Patient Problem/Medical Problem	4	4
Blood Loss	3	3
Erythema	3	3
Urinary Retention	3	3
Inflammation	3	3
Unspecified Musculoskeletal problem	3	3
Arthralgia	3	3